By Document
US FDA · 2020
57 inspection documents published by US FDA in 2020. Open a document to see every finding from that inspection.
Potter's House Apothecary, Inc.Aseptic processing and sterility assurance
2020-12-30
3 findings
Family Pharmacy of StatesvilleAseptic processing and sterility assurance · Equipment and facility · Other quality system · Contamination control
2020-12-29
9 findings
Healthy Choice Compounding LLCOther quality system · Material and supplier control · Contamination control
2020-12-22
3 findings
Stokes Healthcare Inc. dba Epicur PharmaComplaint and recall handling · Deviation, CAPA, and investigation · Process validation
2020-12-22
4 findings
EHT Pharmacy LLC dba CurexaContamination control · Laboratory and QC controls · Equipment and facility
2020-12-22
3 findings
Advanced Nutriceuticals, LLCAseptic processing and sterility assurance · Equipment and facility · Contamination control
2020-12-16
12 findings
Juno Therapeutics, Inc.Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system
2020-12-04
3 findings
Vital Care of Dickson, LLC.Other quality system · Aseptic processing and sterility assurance
2020-11-20
4 findings
STAQ Pharma, Inc.Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Labeling and packaging
2020-11-02
5 findings
Edge Pharma, LLCAseptic processing and sterility assurance · Regulatory reporting and change control · Deviation, CAPA, and investigation · Labeling and packaging · Material and supplier control · Computer system validation · Equipment and facility · Process validation
2020-10-08
13 findings
Front Range Laboratories, IncorporatedOther quality system · Aseptic processing and sterility assurance · Laboratory and QC controls
2020-09-21
3 findings
MasterPharm LLCEquipment and facility · Contamination control · Validation and qualification · Training and personnel · Aseptic processing and sterility assurance
2020-07-29
6 findings
RC Outsourcing LLCLaboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Stability and storage
2020-07-09
6 findings
John L. McClellan Memorial Veterans HospitalContamination control · Aseptic processing and sterility assurance · Equipment and facility · Other quality system
2020-07-01
8 findings
Medical Center Pharmacy, Inc.Aseptic processing and sterility assurance · Contamination control
2020-07-01
10 findings
Farmakeio Outsourcing LLCLabeling and packaging · Other quality system · Aseptic processing and sterility assurance
2020-06-18
3 findings
RC Outsourcing LLCStability and storage · Laboratory and QC controls · Deviation, CAPA, and investigation
2020-05-05
4 findings
VA New Jersey Health Care SystemContamination control · Aseptic processing and sterility assurance · Other quality system
2020-05-04
7 findings
The Medicine Shoppe PharmacyAseptic processing and sterility assurance · Equipment and facility · Training and personnel · Environmental monitoring
2020-05-04
13 findings
Empower Clinic Services, LLCLabeling and packaging · Regulatory reporting and change control · Process validation · Quality unit oversight · Other quality system · Aseptic processing and sterility assurance
2020-05-04
6 findings
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterAseptic processing and sterility assurance · Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls
2020-05-04
8 findings
Accurate RX Pharmacy Consulting LLCAseptic processing and sterility assurance
2020-05-04
3 findings
La Vita Compounding Pharmacy, LLCMaterial and supplier control · Aseptic processing and sterility assurance · Training and personnel
2020-05-04
4 findings
Shilpa Medicare Ltd.Other quality system · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility
2020-04-02
5 findings
Biocon Sdn BhdAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight
2020-04-02
3 findings
Immunomedics Inc.Material and supplier control · Other quality system · Quality unit oversight · Stability and storage · Equipment and facility
2020-04-02
9 findings
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyAseptic processing and sterility assurance · Training and personnel · Stability and storage
2020-03-18
5 findings
Vita Pharmacy, LLC dba Talon Pharmacy of BoerneOther quality system · Cleaning validation · Aseptic processing and sterility assurance · Environmental monitoring
2020-03-09
6 findings
Maitland Labs of Central FloridaAseptic processing and sterility assurance · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage
2020-03-09
7 findings
Maitland Labs of Central FloridaStability and storage · Aseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging · Equipment and facility
2020-03-09
8 findings
Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalsDeviation, CAPA, and investigation · Training and personnel · Equipment and facility · Aseptic processing and sterility assurance · Quality unit oversight · Documentation and records
2020-03-09
7 findings
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyAseptic processing and sterility assurance · Material and supplier control · Contamination control
2020-03-09
10 findings
Premier Pharmacy Labs IncStability and storage · Labeling and packaging · Contamination control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Process validation
2020-03-09
14 findings
Blount Discount Pharmacy, Inc.Material and supplier control · Equipment and facility
2020-03-09
3 findings
Biocon Ltd.Quality unit oversight · Equipment and facility · Material and supplier control · Other quality system
2020-03-06
4 findings
Nanobots Healthcare, LLC dba Assurance InfusionAseptic processing and sterility assurance · Other quality system · Validation and qualification
2020-02-24
9 findings
DynaLabs LLCLaboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight
2020-02-24
5 findings
McAlister Drug CorporationMaterial and supplier control · Stability and storage · Equipment and facility · Contamination control
2020-02-24
4 findings
SSM Health Care St. Louis DBA SSM St. Clare Health CenterQuality unit oversight · Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel
2020-02-24
8 findings
Claremore Compounding Center, Inc.Material and supplier control · Laboratory and QC controls · Stability and storage
2020-02-24
3 findings
Tailor Made Compounding, LLCAseptic processing and sterility assurance · Contamination control · Laboratory and QC controls · Material and supplier control · Stability and storage · Deviation, CAPA, and investigation · Equipment and facility · Process validation
2020-02-21
11 findings
Dr. Reddy's Laboratories Limited CTO Unit VIOther quality system · Process validation · Deviation, CAPA, and investigation
2020-02-05
3 findings
Hawaii Health Systems Corporation dba Kona Community Hospital PharmacyAseptic processing and sterility assurance · Equipment and facility · Other quality system · Training and personnel
2020-02-04
7 findings
Lupin LimitedMaterial and supplier control · Deviation, CAPA, and investigation · Other quality system · Process validation
2020-02-04
4 findings
Fairview Compounding PharmacyAseptic processing and sterility assurance · Validation and qualification · Contamination control
2020-02-03
5 findings
Liveyon Labs IncOther quality system · Equipment and facility · Contamination control · Aseptic processing and sterility assurance · Stability and storage · Deviation, CAPA, and investigation · Complaint and recall handling
2020-02-03
9 findings
Mandell's Clinical PharmacyAseptic processing and sterility assurance · Contamination control · Other quality system
2020-01-31
4 findings
Athenex Pharma Solutions, LLCEquipment and facility · Labeling and packaging · Aseptic processing and sterility assurance
2020-01-28
4 findings
New Era Pharmacy, LLCContamination control · Material and supplier control · Aseptic processing and sterility assurance · Validation and qualification
2020-01-27
4 findings
Foothills Professional Pharmacy, Ltd.Laboratory and QC controls · Quality unit oversight · Other quality system · Equipment and facility · Stability and storage · Process validation
2020-01-27
7 findings
Avenue Pharmacy Inc. dba Pathway PharmacyContamination control · Other quality system
2020-01-16
3 findings
Right Value Drug Stores, LLC dba Carie Boyd’s Prescription ShopAseptic processing and sterility assurance · Regulatory reporting and change control · Complaint and recall handling · Material and supplier control
2020-01-16
6 findings
MPRX, Inc. dba Medical Park PharmacyEquipment and facility · Other quality system · Contamination control
2020-01-07
4 findings
McGuff Compounding Pharmacy Services, Inc.Aseptic processing and sterility assurance · Contamination control · Equipment and facility · Material and supplier control
2020-01-07
7 findings
Abilene Nuclear LLC dba National Central PharmacyAseptic processing and sterility assurance · Documentation and records · Equipment and facility
2020-01-07
8 findings
SCA Pharmaceuticals, Inc.Training and personnel · Computer system validation · Documentation and records · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls
2020-01-07
6 findings
Apex Pharmacy, LLCAseptic processing and sterility assurance · Contamination control · Material and supplier control
2020-01-07
3 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.
