FDA Inspection
L. Perrigo CompanyL. Perrigo Company – FDA Inspection, Nov 7, 2008
Record Details
This FDA Inspection record concerns L. Perrigo Company, with an inspection on November 7, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- L. Perrigo Company
- Inspection Date
- November 7, 2008
- Product Type
- Drugs
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ID · ca2fcc94-d0b2-4798-b4d7-e131bd888247
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544056
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
10- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of L. Perrigo Company
20| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2026 | Not classified | Detroit District Office | |
| March 19, 2025 | VAI | Detroit District Office | Drug Quality Assurance |
| October 6, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 17, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 11, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for L. Perrigo Company
- FDA Inspection 1303150 - 2026-02-20
- FDA Inspection 1251186 - 2025-03-19
- FDA Inspection 1221191 - 2023-10-06
- FDA Inspection 1076466 - 2019-01-17
- FDA Inspection 906986 - 2014-12-11
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