FDA Inspection
Playtex Manufacturing, Inc. - Plant #2Playtex Manufacturing, Inc. - Plant #2 – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Playtex Manufacturing, Inc. - Plant #2, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6b9a923d-4554-42a9-b795-fe43f8112cad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102055
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Playtex Manufacturing, Inc. - Plant #2
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2025 | VAI | Cincinnati District Office | Drug Quality Assurance |
| January 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Playtex Manufacturing, Inc. - Plant #2
- FDA Inspection 1266386 - 2025-04-07
- FDA Inspection 865806 - 2014-01-06
- FDA Inspection 718235 - 2011-02-23
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