FDA Inspection
Warner Chilcott Company LLCWarner Chilcott Company LLC – FDA Inspection, Oct 3, 2016
Record Details
This FDA Inspection record concerns Warner Chilcott Company LLC, with an inspection on October 3, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Marian E. Ramirez (Company Rep)
- Vilmary Negron Rodriguez (Issuing Officer)
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ID · f98cd0ab-b2ff-4f31-8b46-9ac4a76f4042
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988930
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Warner Chilcott Company LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Warner Chilcott Company LLC
- FDA Inspection 903590 - 2014-10-30
- FDA Inspection 655951 - 2010-04-05
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