By Document
US FDA · 2023
119 inspection documents published by US FDA in 2023. Open a document to see every finding from that inspection.
Laurus Synthesis Private LimitedOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Documentation and records
2023-12-28
5 findings
Dr. Reddy's Laboratories LimitedTraining and personnel · Laboratory and QC controls
2023-12-28
3 findings
Torrent Pharmaceuticals LimitedDeviation, CAPA, and investigation · Quality unit oversight · Laboratory and QC controls · Equipment and facility · Material and supplier control
2023-12-28
5 findings
ModernaTX, Inc.Equipment and facility · Cleaning validation · Other quality system
2023-12-27
5 findings
Dextrum Laboratories Inc.Material and supplier control · Process validation
2023-12-26
3 findings
Colonial Dames Company, LtdCleaning validation · Equipment and facility · Stability and storage · Process validation · Quality unit oversight
2023-12-26
5 findings
SCA Pharmaceuticals, LLC.Aseptic processing and sterility assurance · Complaint and recall handling · Equipment and facility · Quality unit oversight · Labeling and packaging · Computer system validation · Other quality system · Deviation, CAPA, and investigation
2023-12-19
10 findings
Kilitch Healthcare India LimitedAseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Quality unit oversight · Other quality system · Documentation and records · Material and supplier control
2023-11-29
11 findings
Dr. Reddy's Laboratories Ltd.Other quality system · Equipment and facility · Complaint and recall handling · Laboratory and QC controls · Computer system validation · Quality unit oversight · Process validation
2023-11-29
9 findings
Kilitch Healthcare India LimitedLaboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight · Equipment and facility · Documentation and records · Material and supplier control
2023-11-28
11 findings
Intas Pharmaceuticals LimitedAseptic processing and sterility assurance · Process validation · Quality unit oversight
2023-11-28
4 findings
Melanie M. Hoppers, M.D./Physicians Quality CareLaboratory and QC controls
2023-11-21
4 findings
Cipla LimitedAseptic processing and sterility assurance · Quality unit oversight · Complaint and recall handling
2023-11-21
3 findings
Xiamen Wally Bath Manufacture Co., Ltd.Stability and storage · Material and supplier control · Laboratory and QC controls
2023-11-21
3 findings
Central Admixture Pharmacy Services, Inc.Quality unit oversight · Equipment and facility · Stability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance · Other quality system · Process validation · Documentation and records · Labeling and packaging · Validation and qualification · Deviation, CAPA, and investigation
2023-11-15
19 findings
Global Pharma Healthcare Private LimitedAseptic processing and sterility assurance · Quality unit oversight
2023-11-14
4 findings
Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu SubesiMaterial and supplier control · Stability and storage · Laboratory and QC controls
2023-11-14
3 findings
Natco Pharma LimitedDeviation, CAPA, and investigation · Quality unit oversight · Aseptic processing and sterility assurance · Process validation · Equipment and facility · Computer system validation
2023-11-01
8 findings
New Vitalis Pharmacy LLCAseptic processing and sterility assurance · Equipment and facility · Other quality system · Contamination control
2023-11-01
11 findings
SterRx LLCEquipment and facility · Material and supplier control · Aseptic processing and sterility assurance · Contamination control
2023-11-01
6 findings
Pine Pharmaceuticals LLCRegulatory reporting and change control · Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Equipment and facility
2023-11-01
7 findings
Samm Solutions, Inc., d.b.a. BTS ResearchDeviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility
2023-10-31
5 findings
ALI Pharmaceutical Manufacturing, LLCOther quality system · Process validation · Complaint and recall handling
2023-10-31
3 findings
Panacea Biotec Pharma Ltd.Aseptic processing and sterility assurance · Training and personnel · Quality unit oversight · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation
2023-10-20
9 findings
Handock Cosmetics Co., Ltd.Material and supplier control · Quality unit oversight · Equipment and facility
2023-10-17
3 findings
Sun Pharmaceutical Industries Ltd.Cleaning validation · Equipment and facility · Environmental monitoring · Aseptic processing and sterility assurance
2023-10-16
7 findings
Surgery Pharmacy Services IncEquipment and facility · Aseptic processing and sterility assurance
2023-10-12
3 findings
Strive Pharmacy Texas LLCEquipment and facility · Aseptic processing and sterility assurance
2023-10-12
4 findings
Spectrum Laboratory ProductsQuality unit oversight · Cleaning validation · Validation and qualification · Documentation and records · Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system · Complaint and recall handling · Stability and storage · Contamination control
2023-10-05
12 findings
Signature Biologics, LLCAseptic processing and sterility assurance · Stability and storage · Process validation
2023-09-29
7 findings
Southern Tier Home Infusion, Inc. dba Pharmacy InnovationsAseptic processing and sterility assurance · Environmental monitoring · Contamination control · Other quality system · Cleaning validation
2023-09-29
18 findings
Fresenius Kabi AGAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Cleaning validation
2023-09-29
6 findings
SNF Holdings LLCContamination control · Material and supplier control
2023-09-27
3 findings
Nephron Sterile Compounding Center LLCQuality unit oversight · Aseptic processing and sterility assurance · Contamination control · Process validation · Equipment and facility · Laboratory and QC controls · Training and personnel
2023-09-25
13 findings
Reliant Compounded Solutions Monroe, LLCOther quality system · Aseptic processing and sterility assurance · Training and personnel
2023-09-22
4 findings
PureChemPros LLCQuality unit oversight · Material and supplier control · Stability and storage
2023-09-19
3 findings
Kor-Chem, Inc.Laboratory and QC controls · Equipment and facility · Material and supplier control · Quality unit oversight
2023-09-19
4 findings
Similasan AGAseptic processing and sterility assurance · Laboratory and QC controls
2023-09-12
4 findings
Safecor Health, LLCCleaning validation · Equipment and facility · Quality unit oversight · Material and supplier control
2023-09-12
4 findings
Lex Inc.Computer system validation · Quality unit oversight
2023-09-05
4 findings
Gadal Laboratories Inc.Material and supplier control · Quality unit oversight
2023-08-29
3 findings
K.C. Pharmaceuticals Inc.Aseptic processing and sterility assurance
2023-08-29
3 findings
Cosmobeauti Laboratories & Manufacturing Inc.Quality unit oversight · Documentation and records · Laboratory and QC controls
2023-08-29
3 findings
Denison Pharmaceuticals, LLCDeviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls
2023-08-15
3 findings
Biocon Sdn. Bhd.Aseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Material and supplier control · Other quality system · Laboratory and QC controls
2023-08-14
6 findings
US Specialty Formulations, LLCContamination control · Stability and storage · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Environmental monitoring · Other quality system
2023-08-08
29 findings
LXR Biotech, LLCLaboratory and QC controls · Complaint and recall handling · Process validation · Material and supplier control
2023-08-01
4 findings
Intas Pharmaceuticals LimitedEnvironmental monitoring · Data integrity · Computer system validation · Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation
2023-08-01
12 findings
RenatiLabs Inc.Aseptic processing and sterility assurance · Stability and storage · Process validation · Other quality system · Documentation and records · Environmental monitoring
2023-08-01
9 findings
Iso-Tex Diagnostics, Inc.Aseptic processing and sterility assurance · Laboratory and QC controls
2023-08-01
3 findings
Jamol Laboratories, Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Process validation
2023-08-01
3 findings
Baxter Healthcare CorporationAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility
2023-08-01
4 findings
Avlon Industries, Inc.Material and supplier control · Process validation · Quality unit oversight
2023-08-01
3 findings
Central AdmixtureContamination control · Laboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Computer system validation
2023-07-27
6 findings
Stratus Biosystems, LLC dba CellGenuity Regenerative ScienceAseptic processing and sterility assurance · Process validation · Stability and storage
2023-07-25
6 findings
Catalent Indiana LLCOther quality system · Aseptic processing and sterility assurance
2023-07-21
5 findings
SCA PharmaceuticalsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility
2023-07-19
4 findings
SentaraValidation and qualification · Aseptic processing and sterility assurance · Contamination control
2023-07-19
9 findings
Apollo Care LLCLabeling and packaging · Other quality system
2023-07-13
3 findings
Row1 Inc. dba Regenative LabsProcess validation · Aseptic processing and sterility assurance · Stability and storage
2023-07-11
3 findings
The New Hope Center for Reproductive MedicineOther quality system · Stability and storage
2023-07-11
8 findings
Intas Pharmaceuticals LimitedAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Computer system validation · Other quality system · Laboratory and QC controls · Documentation and records · Contamination control · Deviation, CAPA, and investigation · Process validation
2023-07-05
16 findings
Ipca Laboratories LimitedComplaint and recall handling · Training and personnel · Process validation · Laboratory and QC controls · Quality unit oversight · Deviation, CAPA, and investigation
2023-07-05
7 findings
Prisma HealthAseptic processing and sterility assurance · Quality unit oversight
2023-06-28
3 findings
Safe Chain Solutions, LLCOther quality system · Deviation, CAPA, and investigation
2023-06-27
4 findings
Pharmacy Plus, Inc., dba Vital Care CompounderAseptic processing and sterility assurance · Training and personnel · Cleaning validation · Equipment and facility · Contamination control
2023-06-13
16 findings
Carolina InfusionLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Validation and qualification · Material and supplier control · Regulatory reporting and change control · Other quality system · Training and personnel · Documentation and records
2023-06-13
17 findings
RemedyRepack, Inc.Laboratory and QC controls · Process validation · Equipment and facility · Deviation, CAPA, and investigation
2023-06-06
4 findings
ImprimisRx NJAseptic processing and sterility assurance · Equipment and facility · Environmental monitoring · Training and personnel
2023-06-06
9 findings
Mr. Lulu LLCMaterial and supplier control · Deviation, CAPA, and investigation · Documentation and records · Laboratory and QC controls
2023-06-06
4 findings
New England Life Care, Inc. dba Advanced Compounding SolutionsOther quality system · Environmental monitoring · Complaint and recall handling · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation · Material and supplier control · Stability and storage
2023-05-30
30 findings
UCB Pharma SA, BraineQuality unit oversight · Material and supplier control · Training and personnel
2023-05-25
3 findings
Sure-Biochem Laboratories, LLCQuality unit oversight · Laboratory and QC controls
2023-05-23
3 findings
Nephron PharmaceuticalsLaboratory and QC controls · Stability and storage · Training and personnel · Quality unit oversight
2023-05-16
4 findings
Pharmedica USA, LLCLaboratory and QC controls · Quality unit oversight · Process validation · Aseptic processing and sterility assurance · Material and supplier control
2023-05-16
5 findings
Drivergent, Inc.Material and supplier control · Quality unit oversight · Laboratory and QC controls · Equipment and facility
2023-05-09
4 findings
Premier Nutra Pharma Inc.Documentation and records · Deviation, CAPA, and investigation · Environmental monitoring
2023-05-09
4 findings
Rentschler Biopharma SEOther quality system · Contamination control · Quality unit oversight
2023-05-05
3 findings
Alvotech HfAseptic processing and sterility assurance · Computer system validation · Other quality system · Equipment and facility · Quality unit oversight · Validation and qualification
2023-04-26
7 findings
Ajinomoto Althea, Inc.Equipment and facility · Quality unit oversight · Validation and qualification
2023-04-25
3 findings
Accra-Pac, Inc. dba Voyant BeautyDeviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls
2023-04-25
3 findings
Lupin LimitedDeviation, CAPA, and investigation · Quality unit oversight · Complaint and recall handling · Training and personnel · Computer system validation · Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls
2023-04-19
10 findings
Chemical Services Group, Inc./Royal Chemical CompanyQuality unit oversight · Material and supplier control · Equipment and facility
2023-04-18
4 findings
Zermat International S.A. de C.V.Process validation · Deviation, CAPA, and investigation · Quality unit oversight
2023-04-18
3 findings
Eco Lips, Inc.Deviation, CAPA, and investigation · Cleaning validation · Stability and storage · Quality unit oversight
2023-04-18
4 findings
Lupin LimitedDeviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Training and personnel
2023-04-14
10 findings
Omega Packaging CorpMaterial and supplier control · Cleaning validation · Process validation
2023-04-11
3 findings
QuVa Pharma, Inc.Training and personnel · Stability and storage · Laboratory and QC controls
2023-04-05
3 findings
Global Pharma Healthcare Ltd.Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Laboratory and QC controls · Quality unit oversight
2023-03-30
11 findings
NuGeneration Technologies LLCProcess validation · Stability and storage · Laboratory and QC controls · Material and supplier control
2023-03-28
4 findings
Cosmetic Science Laboratories LLCQuality unit oversight · Material and supplier control · Documentation and records
2023-03-21
3 findings
Dunagin Pharmaceuticals Inc. dba Massco DentalDeviation, CAPA, and investigation · Material and supplier control · Process validation · Equipment and facility · Laboratory and QC controls
2023-03-21
5 findings
Atlantic Management Resources LTD dba. Claire Ellen ProductsDocumentation and records · Quality unit oversight · Material and supplier control
2023-03-14
3 findings
B & J GroupLaboratory and QC controls · Process validation · Material and supplier control
2023-03-14
3 findings
Profounda, Inc.Laboratory and QC controls · Process validation · Stability and storage · Quality unit oversight · Equipment and facility
2023-03-14
5 findings
Midlab IncorporatedDeviation, CAPA, and investigation · Documentation and records · Complaint and recall handling
2023-03-14
4 findings
Maggie Jeffries, M.D. / Avanti Anesthesiology, LLCDeviation, CAPA, and investigation
2023-03-14
5 findings
Frenda CorporationQuality unit oversight · Material and supplier control · Cleaning validation · Process validation
2023-03-14
4 findings
Cipla LimitedAseptic processing and sterility assurance · Other quality system · Computer system validation · Quality unit oversight · Deviation, CAPA, and investigation · Complaint and recall handling
2023-03-02
8 findings
Gascó Industrial CorporationQuality unit oversight · Equipment and facility · Cleaning validation
2023-02-28
3 findings
Ultra Chem Labs CorporationLaboratory and QC controls · Quality unit oversight · Material and supplier control
2023-02-28
3 findings
Skyless, LLCLaboratory and QC controls · Quality unit oversight · Material and supplier control
2023-02-28
3 findings
Barclay, Luke, & Pillai Specialty Pharmacy, PLLCContamination control · Material and supplier control · Aseptic processing and sterility assurance · Laboratory and QC controls · Environmental monitoring
2023-02-23
7 findings
Amneal Pharmaceuticals Private Ltd.Aseptic processing and sterility assurance · Equipment and facility · Validation and qualification · Other quality system · Environmental monitoring
2023-02-22
6 findings
Northern VA Compounders PLLCContamination control · Aseptic processing and sterility assurance · Material and supplier control · Training and personnel
2023-02-21
8 findings
Clean Cosmetics LLCLaboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation
2023-02-14
3 findings
Delta Kozmetik Sanayi Ve Ticaret-Selim YesilProcess validation · Equipment and facility · Material and supplier control
2023-02-14
3 findings
Wells Pharma of Houston LLCEquipment and facility · Quality unit oversight
2023-02-03
3 findings
RC Outsourcing LLCAseptic processing and sterility assurance · Equipment and facility · Contamination control · Quality unit oversight · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system
2023-02-03
10 findings
Fei Fah Medical Manufacturing Pte. Ltd.Stability and storage · Material and supplier control · Laboratory and QC controls
2023-01-31
3 findings
First Royal Care Co. LLC, dba Red Mountain CompoundingValidation and qualification · Equipment and facility · Contamination control
2023-01-30
3 findings
PQ Pharmacy LLCAseptic processing and sterility assurance · Quality unit oversight · Laboratory and QC controls · Regulatory reporting and change control · Stability and storage
2023-01-30
6 findings
Southern Tier Home Infusion, Inc. dba Pharmacy InnovationsAseptic processing and sterility assurance · Equipment and facility · Other quality system
2023-01-30
9 findings
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingEnvironmental monitoring · Aseptic processing and sterility assurance · Contamination control · Documentation and records · Cleaning validation
2023-01-24
9 findings
Intas Pharmaceuticals Ltd.Stability and storage · Deviation, CAPA, and investigation · Quality unit oversight · Computer system validation · Laboratory and QC controls · Process validation · Aseptic processing and sterility assurance · Other quality system
2023-01-18
11 findings
Hikma Injectables USA Inc.Aseptic processing and sterility assurance · Stability and storage
2023-01-18
3 findings
Optum Infusion Services 308 LLCAseptic processing and sterility assurance · Other quality system · Training and personnel
2023-01-17
6 findings
Auto-Chlor System LLCProcess validation · Quality unit oversight · Material and supplier control · Cleaning validation
2023-01-10
4 findings
Superior Glove Works, Ltd.Documentation and records · Material and supplier control · Laboratory and QC controls
2023-01-03
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.
