FDA Inspection
L. Perrigo CompanyL. Perrigo Company – FDA Inspection, Jan 17, 2019
Record Details
This FDA Inspection record concerns L. Perrigo Company, with an inspection on January 17, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Emily J. Stoklosa (Issuing Officer)
- Sandra A. Boyd (Investigator)
View Company Profile
ID · cd195569-ba97-4680-a2e1-fe0c6fe98713
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076466
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.67(b)Written procedures fail to include
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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 |
| December 11, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 4, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 906986 - 2014-12-11
- FDA Inspection 894507 - 2014-09-04
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