# FDA 483 - L. Perrigo Company - November 07, 2008

Source: https://www.keypedia.com/records/483/l-perrigo-company/e35921dd-708b-4d92-a3b1-57a2ea97e42a

> FDA 483 for L. Perrigo Company on November 07, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: L. Perrigo Company
- Inspection Date: 2008-11-07
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA Form 483 details multiple significant violations at a drug manufacturing facility, encompassing issues with quality control, record-keeping, and product release.

**Key Violations and Observations:**

*   **Unapproved Expiration Dates:** Numerous drug lots, including Sleep Aid Tablets (Doxylamine Succinate 25 mg), Naproxen Sodium 220 tablets/caplets, and APAP 500 mg Gelcaps, were released with unapproved expiration dates (36 or 48 months) not compliant with established procedures.
*   **Inadequate Investigation of Out-of-Specification (OOS) Results:**
    *   Multiple lots of Natural Senna Laxative Tablets, some manufactured by (b)(4), failed stability assays and remained on the market despite unresolved investigations. Examples include lots 7B0991, 7G0903, and 6GE0670.
    *   An OOS release assay for Natural Senna Laxative Tablet lot 7E1788 remained unresolved, and subsequent lots were released without prior testing.
    *   OOS stability results for Chlorpheniramine Maleate Tablet lot 6F1461 (JB Laboratories) and 81 mg Enteric Coated Aspirin tablet lot 6E0507 (b)(4) were not resolved.
*   **Failure to Review Discrepancies:**

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## Related Officers

- [Investigator](https://www.keypedia.com/people/regina-t-brown/6e2de1b6-3e5d-40ec-8823-7f0aef908b2b)

Company: https://www.keypedia.com/companies/l-perrigo-company/47babd74-e5cb-4ab8-959e-35b9d1157e0b

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03