FDA Inspection
Wyeth Lederle S.r.lWyeth Lederle S.r.l – FDA Inspection, Apr 20, 2017
Record Details
This FDA Inspection record concerns Wyeth Lederle S.r.l, with an inspection on April 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 68b006c2-563c-4bdd-868c-dd5ef6220979
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012188
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Wyeth Lederle S.r.l
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 14, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Wyeth Lederle S.r.l
- FDA Inspection 1178127 - 2022-01-21
- FDA Inspection 903600 - 2014-11-14
- FDA Inspection 792624 - 2012-07-20
- FDA Inspection 637083 - 2009-12-04
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