By Document
US FDA · 2021
77 inspection documents published by US FDA in 2021. Open a document to see every finding from that inspection.
Ideal Specialty Apothecary, Inc. dba Ideal PharmacyOther quality system · Aseptic processing and sterility assurance · Validation and qualification · Equipment and facility · Contamination control
2021-12-30
7 findings
Optum Compounding Services, LLCDeviation, CAPA, and investigation · Other quality system · Quality unit oversight
2021-12-22
3 findings
Vita Pharmacy, LLC dba Talon Compounding PharmacyEquipment and facility · Contamination control · Validation and qualification
2021-12-22
3 findings
Bhaumik Diversified LLC dba Texas Star PharmacyOther quality system · Material and supplier control · Aseptic processing and sterility assurance · Contamination control
2021-12-17
11 findings
Providence Health and Services Washington Dba Providence Infusion Hospital ServicesAseptic processing and sterility assurance · Labeling and packaging · Regulatory reporting and change control
2021-12-17
4 findings
Dental Technologies Inc.Deviation, CAPA, and investigation · Laboratory and QC controls · Documentation and records · Cleaning validation
2021-12-14
5 findings
Cooper InstituteOther quality system · Contamination control
2021-12-14
5 findings
Sanitor CorporationComputer system validation · Deviation, CAPA, and investigation · Laboratory and QC controls
2021-12-14
3 findings
Dr. Reddy's Laboratories Ltd.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Laboratory and QC controls · Contamination control
2021-12-06
7 findings
Surgenex LLCAseptic processing and sterility assurance · Stability and storage
2021-11-23
4 findings
InfuScience , Inc . dba Bioscrip Infusion ServicesAseptic processing and sterility assurance · Validation and qualification
2021-11-19
4 findings
Pharmcore Inc. dba Hallandale PharmacyAseptic processing and sterility assurance · Cleaning validation
2021-11-19
3 findings
Matthew 7:25 Inc dba Thrive PharmacyLaboratory and QC controls · Process validation · Stability and storage
2021-11-16
3 findings
Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular MedicineOther quality system · Quality unit oversight · Contamination control · Aseptic processing and sterility assurance · Cleaning validation · Equipment and facility · Process validation · Environmental monitoring · Documentation and records · Training and personnel · Material and supplier control
2021-11-16
38 findings
Infusion Options, Inc.Stability and storage · Process validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Contamination control
2021-11-09
13 findings
Revive Rx, LLC dba Revive Rx PharmacyAseptic processing and sterility assurance · Validation and qualification · Material and supplier control
2021-10-28
5 findings
ACRX Specialty Pharmacy lncAseptic processing and sterility assurance · Material and supplier control · Contamination control
2021-10-28
4 findings
IntegraDose Compounding Services LLCQuality unit oversight · Aseptic processing and sterility assurance
2021-10-28
4 findings
First Royal Care Co. LLC, dba Red Mountain CompoundingTraining and personnel · Material and supplier control · Contamination control · Other quality system · Laboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage · Environmental monitoring
2021-10-28
15 findings
Empower Clinic Services, LLC dba Empower PharmacyEquipment and facility
2021-10-26
4 findings
Biocon Sdn. Bhd.Equipment and facility · Other quality system · Cleaning validation
2021-10-25
4 findings
Atlas Pharmaceuticals, LLCLaboratory and QC controls · Aseptic processing and sterility assurance
2021-10-20
3 findings
Colonia Care PharmacyContamination control · Aseptic processing and sterility assurance
2021-10-20
3 findings
Innoveix Pharmaceuticals IncAseptic processing and sterility assurance
2021-10-20
8 findings
Jon B. Cole, MDDeviation, CAPA, and investigation
2021-10-19
5 findings
Lauren R. Klein, MD, M.S.Deviation, CAPA, and investigation
2021-10-19
6 findings
Revance Therapeutics, Inc.Other quality system · Quality unit oversight
2021-10-12
4 findings
Compounded Solutions in Pharmacy, LLCEquipment and facility · Aseptic processing and sterility assurance · Other quality system · Training and personnel
2021-10-07
6 findings
BAYCARE INTEGRATED SERVICE CENTERAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Other quality system
2021-10-05
5 findings
People's Custom Rx and Clinical Care, LLCAseptic processing and sterility assurance · Contamination control
2021-10-05
3 findings
Walfer Corporation dba The Medicine Shoppe PharmacyCleaning validation · Equipment and facility · Contamination control · Other quality system
2021-10-05
10 findings
Central Admixture Pharmacy Services IncAseptic processing and sterility assurance · Other quality system
2021-09-24
4 findings
Pine Pharmaceuticals, LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls · Quality unit oversight
2021-09-24
5 findings
Nanomateriales Químicos Avanzados, S.A. de C.V.Material and supplier control · Quality unit oversight · Laboratory and QC controls
2021-09-21
3 findings
Prescription Labs Inc dba GreenparkValidation and qualification · Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Contamination control
2021-09-17
9 findings
Age Management Institute Santa BarbaraMaterial and supplier control · Other quality system · Contamination control · Aseptic processing and sterility assurance
2021-09-10
4 findings
Toyobo Co.Deviation, CAPA, and investigation · Quality unit oversight · Computer system validation · Training and personnel · Laboratory and QC controls · Documentation and records · Process validation · Aseptic processing and sterility assurance
2021-09-03
11 findings
Gulsah Uretim Kozmetik Sanayi Anonim SirketiMaterial and supplier control · Stability and storage · Laboratory and QC controls
2021-08-31
3 findings
Fujifilm Diosynth Biotechnologies USAComputer system validation · Deviation, CAPA, and investigation · Equipment and facility · Material and supplier control · Other quality system
2021-08-26
7 findings
Aurobindo Pharma Limited Unit 1Equipment and facility · Other quality system
2021-08-24
3 findings
Natural Beauty Care Pty LtdMaterial and supplier control · Laboratory and QC controls · Stability and storage
2021-08-24
3 findings
Jubilant Generics LimitedDeviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Process validation · Computer system validation · Quality unit oversight
2021-08-17
7 findings
Utah Cord Bank LLC dba Utah Cell BankLabeling and packaging · Aseptic processing and sterility assurance · Material and supplier control · Stability and storage · Documentation and records · Process validation · Complaint and recall handling
2021-08-17
14 findings
Maitland Labs of Central FloridaStability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility
2021-08-17
11 findings
Imprimis NJOF, -LLCLaboratory and QC controls · Regulatory reporting and change control · Equipment and facility · Quality unit oversight · Process validation · Deviation, CAPA, and investigation
2021-08-13
7 findings
Eli Lilly and CompanyDeviation, CAPA, and investigation · Laboratory and QC controls · Material and supplier control · Training and personnel · Aseptic processing and sterility assurance · Quality unit oversight
2021-08-12
7 findings
Syntec Pharma CorpEquipment and facility · Quality unit oversight
2021-08-03
3 findings
MasterPharm LLCContamination control · Aseptic processing and sterility assurance · Equipment and facility · Training and personnel
2021-07-27
8 findings
Life Science Pharmacy IncAseptic processing and sterility assurance · Validation and qualification · Environmental monitoring · Material and supplier control
2021-07-07
5 findings
BSO LLCDeviation, CAPA, and investigation · Labeling and packaging · Equipment and facility · Other quality system
2021-06-08
4 findings
Utah Cord Bank LLCEquipment and facility · Other quality system · Contamination control
2021-06-01
4 findings
Hospira IncQuality unit oversight · Contamination control · Documentation and records · Deviation, CAPA, and investigation · Material and supplier control · Process validation · Aseptic processing and sterility assurance
2021-05-24
9 findings
Emergent Manufacturing Operations Baltimore, LLC.Equipment and facility · Material and supplier control · Process validation · Other quality system
2021-05-13
8 findings
Hospira IncAseptic processing and sterility assurance · Documentation and records · Process validation · Quality unit oversight · Deviation, CAPA, and investigation · Contamination control · Material and supplier control
2021-05-05
9 findings
American Specialty Pharmacy, Inc. dba ASP CaresAseptic processing and sterility assurance · Stability and storage · Equipment and facility · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation · Environmental monitoring · Documentation and records
2021-04-27
15 findings
Joe Wise Pharmacy, Inc., dba Wise PharmacyContamination control · Other quality system · Environmental monitoring · Aseptic processing and sterility assurance
2021-04-27
5 findings
Emergent Manufacturing Operations Baltimore LLCComputer system validation · Quality unit oversight · Material and supplier control · Training and personnel · Laboratory and QC controls
2021-04-23
5 findings
Hospira Boulder, Inc.Aseptic processing and sterility assurance · Material and supplier control · Other quality system · Process validation · Laboratory and QC controls
2021-04-21
6 findings
Hospira Inc. A Pfizer CompanyDeviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Training and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage
2021-04-21
10 findings
Hospira Inc. A Pfizer CompanyComplaint and recall handling · Other quality system · Deviation, CAPA, and investigation · Material and supplier control · Process validation · Aseptic processing and sterility assurance · Validation and qualification · Laboratory and QC controls
2021-04-21
15 findings
Maison Terre, LLCEquipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Contamination control
2021-04-13
5 findings
Proquimes S A Productos Quimicos Especializados S.A.Other quality system · Cleaning validation · Equipment and facility · Material and supplier control
2021-04-13
4 findings
Wells Pharmacy, IncTraining and personnel · Regulatory reporting and change control · Complaint and recall handling · Material and supplier control · Documentation and records · Quality unit oversight · Equipment and facility · Other quality system
2021-03-31
11 findings
BioLyte Laboratories, LLCMaterial and supplier control · Labeling and packaging · Stability and storage · Laboratory and QC controls · Validation and qualification
2021-03-22
8 findings
Honest Globe, Inc.Quality unit oversight · Documentation and records
2021-03-22
3 findings
Dibar Nutricional S. de R.L. de C.V.Laboratory and QC controls · Material and supplier control · Stability and storage · Equipment and facility
2021-03-16
4 findings
Foshan Biours Biosciences Co., Ltd.Laboratory and QC controls · Cleaning validation · Stability and storage
2021-03-16
3 findings
KDunn and Associates, P.A. dba HealthQuiltOther quality system · Deviation, CAPA, and investigation
2021-03-02
4 findings
Hawaii Health Systems Corporation dba Kona Community Hospital PharmacyAseptic processing and sterility assurance · Environmental monitoring · Other quality system
2021-02-09
9 findings
Allay Pharmaceuticals, LLCDeviation, CAPA, and investigation · Material and supplier control · Process validation · Quality unit oversight
2021-02-09
4 findings
Fresenius Kabi USA LLCAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Process validation · Quality unit oversight
2021-01-29
5 findings
Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding PharmacyContamination control · Aseptic processing and sterility assurance · Equipment and facility · Training and personnel
2021-01-29
5 findings
Surgery Pharmacy Services, Inc.Aseptic processing and sterility assurance · Equipment and facility · Validation and qualification · Contamination control
2021-01-29
9 findings
Professional Compounding Centers of America dba PCCAOther quality system · Data integrity · Complaint and recall handling · Deviation, CAPA, and investigation · Material and supplier control
2021-01-27
10 findings
Yuyao YiJia Daily Chemical Co., Ltd.Material and supplier control · Stability and storage · Laboratory and QC controls
2021-01-26
3 findings
Lonza Houston, IncContamination control · Material and supplier control · Other quality system
2021-01-14
4 findings
Novel Laboratories, Inc. d.b.a LUPINLaboratory and QC controls · Computer system validation · Process validation · Stability and storage · Complaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation · Labeling and packaging · Quality unit oversight · Contamination control
2021-01-14
13 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.
