Drug factory · FDA FEI 1810189
Pharmacia & Upjohn Company LLC
7000 Portage Road, Kalamazoo, MI, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 16, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 1 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Sep 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 9, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 20, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 29, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 23, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 28, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 16, 2023 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred. - Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations for its intended use.
Feb 18, 2009 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Procedures Written and Followed 21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.