By Document
US FDA · 2019
117 inspection documents published by US FDA in 2019. Open a document to see every finding from that inspection.
Sun Pharmaceutical Industries Ltd.Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Laboratory and QC controls · Material and supplier control · Quality unit oversight
2019-12-20
8 findings
Techni Med, Inc. dba The CompounderContamination control · Laboratory and QC controls · Aseptic processing and sterility assurance · Material and supplier control
2019-12-18
5 findings
Randol Mill PharmacyProcess validation · Equipment and facility · Stability and storage · Aseptic processing and sterility assurance
2019-12-18
6 findings
Exela Pharma Sciences LLCMaterial and supplier control · Labeling and packaging · Aseptic processing and sterility assurance · Other quality system · Equipment and facility
2019-12-09
6 findings
Atlas Pharmaceuticals, LLCLaboratory and QC controls · Aseptic processing and sterility assurance · Equipment and facility · Training and personnel · Stability and storage · Labeling and packaging
2019-12-09
9 findings
Nubratori, Inc dba Nubratori RxOther quality system · Aseptic processing and sterility assurance
2019-11-27
3 findings
AnazaoHealth CorporationRegulatory reporting and change control · Equipment and facility · Aseptic processing and sterility assurance
2019-11-27
3 findings
RXQ Compounding LLCValidation and qualification · Quality unit oversight · Training and personnel · Equipment and facility · Laboratory and QC controls · Labeling and packaging · Aseptic processing and sterility assurance · Contamination control · Process validation
2019-11-27
11 findings
Aurobindo Pharma Ltd. Unit 5Process validation · Equipment and facility · Aseptic processing and sterility assurance
2019-11-20
3 findings
American Specialty PharmacyAseptic processing and sterility assurance · Equipment and facility · Other quality system · Deviation, CAPA, and investigation
2019-11-14
5 findings
Isorx, Corp.Aseptic processing and sterility assurance · Documentation and records
2019-11-12
3 findings
Medoz Pharmacy of Polk IncTraining and personnel · Aseptic processing and sterility assurance · Validation and qualification · Other quality system · Contamination control · Equipment and facility
2019-11-12
14 findings
Maimonides Medical CenterEnvironmental monitoring · Contamination control · Aseptic processing and sterility assurance · Validation and qualification · Equipment and facility · Other quality system
2019-11-05
16 findings
Innoveix Pharmaceuticals IncAseptic processing and sterility assurance · Equipment and facility · Training and personnel · Other quality system
2019-11-05
8 findings
Roger Williams Medical CenterValidation and qualification · Equipment and facility · Aseptic processing and sterility assurance
2019-11-05
7 findings
PharmScript LLCAseptic processing and sterility assurance · Validation and qualification · Training and personnel · Equipment and facility · Other quality system
2019-10-23
5 findings
PharmScript, LLCAseptic processing and sterility assurance · Contamination control
2019-10-21
4 findings
Stonegate Pharmacy LPTraining and personnel · Aseptic processing and sterility assurance · Other quality system
2019-10-21
3 findings
Shertech Pharmacy, LLCAseptic processing and sterility assurance · Other quality system
2019-10-21
4 findings
Infuscience, Inc. dba Bioscrip Infusion ServicesEquipment and facility · Aseptic processing and sterility assurance · Contamination control · Other quality system
2019-10-21
7 findings
Southern California Compounding Pharmacy, LLCAseptic processing and sterility assurance · Laboratory and QC controls
2019-10-21
3 findings
Synthetopes IncTraining and personnel · Aseptic processing and sterility assurance · Stability and storage · Equipment and facility · Laboratory and QC controls
2019-10-18
6 findings
RAM Pharma, IncAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls
2019-10-18
6 findings
Exela Pharma Sciences LLCDocumentation and records · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility
2019-10-18
7 findings
Cipla LimitedOther quality system · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Material and supplier control
2019-10-11
15 findings
Aurobindo Pharma Ltd.Laboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Process validation · Quality unit oversight
2019-10-09
7 findings
People’s Custom Rx and Clinical Care, LLCContamination control · Aseptic processing and sterility assurance
2019-10-01
3 findings
US Specialty Formulations LLCLaboratory and QC controls · Other quality system · Training and personnel · Stability and storage · Computer system validation · Process validation · Labeling and packaging
2019-09-30
11 findings
Fagron Compounding Service LLC dba Fagron Sterile ServicesAseptic processing and sterility assurance · Labeling and packaging · Other quality system · Contamination control · Quality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls · Regulatory reporting and change control · Equipment and facility
2019-09-16
11 findings
First Royal Care Co. LLC dba Red Mountain Compounding PharmacyDocumentation and records · Stability and storage · Aseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Training and personnel
2019-09-16
12 findings
Anderson Compounding Pharmacy, Inc. dba Anderson Compounding PharmacyContamination control · Aseptic processing and sterility assurance · Other quality system
2019-09-16
4 findings
Shertech PharmacyProcess validation · Material and supplier control · Environmental monitoring · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage
2019-09-16
8 findings
Infusion Treatment Center Inc dba ITC CompoundingMaterial and supplier control · Contamination control · Process validation · Training and personnel · Quality unit oversight
2019-09-15
5 findings
Dr. Reddy's Laboratories Ltd.Deviation, CAPA, and investigation · Process validation · Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Equipment and facility
2019-08-29
8 findings
Shilpa Medicare LimitedEquipment and facility · Computer system validation
2019-08-22
3 findings
Joe Wise Pharmacy, Inc. dba Wise PharmacyMaterial and supplier control · Contamination control · Validation and qualification · Aseptic processing and sterility assurance
2019-08-21
4 findings
First Pharma Associates LLCTraining and personnel · Other quality system · Equipment and facility · Aseptic processing and sterility assurance · Contamination control
2019-08-21
9 findings
Pavilion Compounding PharmacyOther quality system · Contamination control · Documentation and records
2019-08-09
4 findings
AvexisLaboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation
2019-08-08
5 findings
Cipla Ltd. Virgonagar SiteOther quality system · Process validation · Material and supplier control · Labeling and packaging · Documentation and records
2019-07-30
5 findings
Coast Quality Pharmacy, LLC dba Anazao HealthAseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls
2019-07-25
5 findings
Complete Pharmacy and Medical Solutions, LLC dba Complete PharmaceuticsDocumentation and records · Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Laboratory and QC controls · Stability and storage
2019-07-25
6 findings
Rancho Park Compounding PharmacyAseptic processing and sterility assurance · Contamination control · Environmental monitoring · Equipment and facility · Training and personnel
2019-07-25
9 findings
QuVa Pharma, IncQuality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Complaint and recall handling
2019-07-25
6 findings
Metro Drugs 3rd Avenue CorpOther quality system · Aseptic processing and sterility assurance · Equipment and facility · Validation and qualification
2019-07-25
5 findings
QuVa Pharma, IncAseptic processing and sterility assurance · Quality unit oversight · Material and supplier control · Equipment and facility · Other quality system
2019-07-24
6 findings
Pharmacy Plus, Inc. dba Vital Care CompounderLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Training and personnel · Process validation
2019-07-12
10 findings
The Pet Apothecary LLCStability and storage · Training and personnel · Contamination control · Material and supplier control · Other quality system · Complaint and recall handling
2019-07-12
8 findings
Pacifico National, Inc. dba AmEx PharmacyAseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Complaint and recall handling · Material and supplier control · Training and personnel · Stability and storage · Labeling and packaging
2019-07-09
12 findings
Indoco Remedies LimitedMaterial and supplier control · Deviation, CAPA, and investigation · Stability and storage
2019-07-09
3 findings
Sun Pharmaceutical Industries Ltd.Other quality system · Aseptic processing and sterility assurance · Laboratory and QC controls
2019-06-21
4 findings
Aurobindo Pharma Ltd. TelanganaLaboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation · Stability and storage · Complaint and recall handling · Other quality system · Computer system validation · Equipment and facility
2019-06-10
9 findings
Cadila Healthcare Ltd.Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Computer system validation · Quality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls · Process validation · Documentation and records
2019-05-14
14 findings
Promise Pharmacy, LLCOther quality system · Stability and storage · Quality unit oversight · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility
2019-05-13
8 findings
Torrent Pharmaceuticals LimitedDeviation, CAPA, and investigation · Process validation · Equipment and facility
2019-05-02
4 findings
QuVa Pharma, Inc.Material and supplier control · Labeling and packaging · Training and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control
2019-04-30
9 findings
Front Door Pharmacy, LLC dba Pure PharmacyAseptic processing and sterility assurance · Contamination control · Equipment and facility · Validation and qualification
2019-04-30
8 findings
Customceutical Compounding, LLCAseptic processing and sterility assurance · Equipment and facility
2019-04-30
3 findings
Option Care Enterprises, Inc. dba Option CareAseptic processing and sterility assurance · Equipment and facility
2019-04-30
3 findings
ACRX Specialty Pharmacy IncStability and storage · Laboratory and QC controls · Complaint and recall handling · Equipment and facility · Aseptic processing and sterility assurance
2019-04-30
9 findings
QuVa Pharma, IncLabeling and packaging · Laboratory and QC controls · Aseptic processing and sterility assurance · Contamination control · Material and supplier control · Training and personnel
2019-04-30
9 findings
Customceutical Compounding, LLCEquipment and facility · Aseptic processing and sterility assurance
2019-04-30
3 findings
Front Door Pharmacy, LLC dba Pure PharmacyContamination control · Aseptic processing and sterility assurance · Validation and qualification · Equipment and facility
2019-04-30
8 findings
LiveyonLaboratory and QC controls · Stability and storage · Other quality system · Complaint and recall handling · Equipment and facility
2019-04-30
8 findings
Crawford’s Professional Drugs, Inc. dba Diket’s Professional Drugs, Inc.Other quality system · Contamination control · Equipment and facility
2019-04-30
5 findings
Health Solutions Pharmacy Center, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Material and supplier control · Stability and storage · Training and personnel
2019-04-30
10 findings
US Compounding IncMaterial and supplier control · Aseptic processing and sterility assurance · Labeling and packaging · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation
2019-04-30
10 findings
BMD SkincareQuality unit oversight · Laboratory and QC controls · Material and supplier control · Labeling and packaging · Documentation and records · Other quality system · Process validation · Stability and storage
2019-04-30
11 findings
Maple Rose Enterprises, Inc, dba Pencol PharmacyAseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Quality unit oversight · Laboratory and QC controls · Stability and storage
2019-04-30
11 findings
Akorn, Inc.Other quality system · Deviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Material and supplier control · Equipment and facility · Complaint and recall handling
2019-04-30
13 findings
Leiter’s Enterprises, Inc.Training and personnel · Aseptic processing and sterility assurance · Quality unit oversight
2019-04-30
3 findings
Lifetime Value Pharmacy III Inc.Equipment and facility · Contamination control · Aseptic processing and sterility assurance · Environmental monitoring · Training and personnel
2019-04-30
9 findings
Michigan MedicineAseptic processing and sterility assurance · Equipment and facility
2019-04-30
4 findings
Brookfield Medical/Surgical Supply, Inc.Aseptic processing and sterility assurance · Equipment and facility · Process validation · Material and supplier control · Other quality system
2019-04-30
8 findings
Leiter’s Enterprises, Inc.Training and personnel · Aseptic processing and sterility assurance · Quality unit oversight
2019-04-30
3 findings
Leiter’s Enterprises, Inc.Quality unit oversight · Training and personnel · Aseptic processing and sterility assurance
2019-04-30
3 findings
Downing Labs, LLCStability and storage · Aseptic processing and sterility assurance · Equipment and facility
2019-04-30
4 findings
Integrative Pharmacy, LLCStability and storage · Laboratory and QC controls · Material and supplier control
2019-04-30
3 findings
Pharmacy Resources IncorporatedAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage
2019-04-30
6 findings
Barclay, Luke, Pillai Specialty Pharmacy, PLLCAseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Training and personnel · Equipment and facility · Stability and storage · Documentation and records
2019-04-30
10 findings
Dolan Central Illinois Compounding LLC dba Preckshot ProfessionalAseptic processing and sterility assurance · Other quality system · Equipment and facility
2019-04-30
5 findings
ADMA Biologics Inc.Other quality system · Laboratory and QC controls · Equipment and facility · Quality unit oversight
2019-04-30
8 findings
Westlab Pharmacy, Inc. dba Westlab PharmacyAseptic processing and sterility assurance · Material and supplier control · Stability and storage · Laboratory and QC controls
2019-04-30
9 findings
American Specialty PharmacyOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance
2019-04-30
5 findings
Pharm D Solutions, LLCAseptic processing and sterility assurance · Material and supplier control · Documentation and records · Laboratory and QC controls · Training and personnel · Regulatory reporting and change control · Labeling and packaging · Process validation · Stability and storage
2019-04-30
15 findings
Central Admixture Pharmacy Services, Inc.Quality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Documentation and records
2019-04-30
8 findings
Inventive Infusion Solutions, LPContamination control · Aseptic processing and sterility assurance · Environmental monitoring · Other quality system
2019-04-30
8 findings
Sincerus Florida, LLCStability and storage · Process validation · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility · Quality unit oversight
2019-04-30
6 findings
Qualgen LLCEquipment and facility · Process validation · Contamination control · Laboratory and QC controls
2019-04-30
6 findings
Morton Drug Company dba Morton LTCContamination control · Aseptic processing and sterility assurance
2019-04-30
3 findings
Central Admixture Pharmacy Services IncDocumentation and records · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls
2019-04-30
6 findings
Kings Park Slope IncAseptic processing and sterility assurance · Equipment and facility
2019-04-30
4 findings
Loop Plaza Pharmacy Company DBA Loop Compounding PharamacyValidation and qualification · Aseptic processing and sterility assurance · Other quality system
2019-04-30
4 findings
MedisourceRxDocumentation and records · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel
2019-04-30
5 findings
MedisourceRxDocumentation and records · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel
2019-04-30
5 findings
Maag Prescription Center LLCContamination control · Stability and storage
2019-04-30
4 findings
Akorn Inc.Deviation, CAPA, and investigation · Quality unit oversight · Computer system validation · Stability and storage · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Other quality system
2019-04-30
11 findings
PolarityTE, IncAseptic processing and sterility assurance · Process validation · Laboratory and QC controls · Equipment and facility · Quality unit oversight · Contamination control
2019-04-30
7 findings
IntegraDose Compounding Services LLCOther quality system · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Equipment and facility
2019-04-30
6 findings
JCB Laboratories LLCOther quality system · Aseptic processing and sterility assurance · Labeling and packaging · Process validation · Documentation and records · Equipment and facility
2019-04-30
8 findings
White House Pharmacy Inc. dba San Jose Compounding PharmacyContamination control · Material and supplier control
2019-04-30
4 findings
Reed Pharmacy, Inc.Equipment and facility · Laboratory and QC controls · Documentation and records · Other quality system · Stability and storage
2019-04-30
5 findings
Cantrell Drug CompanyEquipment and facility · Computer system validation
2019-04-30
3 findings
Mayo Clinic PharmacyAseptic processing and sterility assurance · Contamination control · Other quality system
2019-04-30
5 findings
Hospira Inc, A Pfizer CompanyMaterial and supplier control · Aseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Complaint and recall handling
2019-04-30
7 findings
Thrifty White Drug #762Aseptic processing and sterility assurance · Validation and qualification
2019-04-30
6 findings
Johnson Memorial Cancer CenterAseptic processing and sterility assurance · Equipment and facility
2019-04-30
6 findings
Med Shop Total Care Inc.Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Training and personnel
2019-04-30
9 findings
Intact Pharmaceuticals LLC.Equipment and facility · Quality unit oversight · Training and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation
2019-04-30
10 findings
Promise Pharmacy, LLCQuality unit oversight · Other quality system · Equipment and facility · Stability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance
2019-04-30
8 findings
Hiers Enterprises, LLC dba Northwest Compounding PharmacyAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Material and supplier control · Training and personnel
2019-04-30
10 findings
Aurobindo Pharma Limited Unit 16Process validation · Deviation, CAPA, and investigation · Training and personnel · Laboratory and QC controls · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Computer system validation
2019-04-08
11 findings
Dr. Reddy's Laboratories LimitedProcess validation · Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls
2019-02-26
4 findings
Dr. Reddy’s Laboratories Ltd.Documentation and records · Computer system validation · Complaint and recall handling · Quality unit oversight · Other quality system · Laboratory and QC controls · Equipment and facility
2019-02-19
11 findings
Indoco Remedies LimitedDeviation, CAPA, and investigation · Documentation and records · Equipment and facility · Laboratory and QC controls
2019-02-12
5 findings
Immunomedics, Inc.Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Data integrity · Equipment and facility · Contamination control
2019-02-12
10 findings
Lupin LimitedDeviation, CAPA, and investigation · Laboratory and QC controls · Complaint and recall handling · Computer system validation · Training and personnel · Equipment and facility
2019-02-08
6 findings
These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. The list includes documents with three or more findings, except for agencies whose documents carry a single finding each (EU/UK GMP non-compliance reports), where that threshold is not applied. Other documents can be found in Findings search. Each document links directly to the source the regulator published.
