FDA Inspection
Wyeth Lederle S.r.lWyeth Lederle S.r.l – FDA Inspection, Nov 14, 2014
Record Details
This FDA Inspection record concerns Wyeth Lederle S.r.l, with an inspection on November 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wyeth Lederle S.r.l
- Inspection Date
- November 14, 2014
- Product Type
- Drugs
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ID · 6eed9d57-b6d1-4bc4-a63b-2b3df655f1e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 903600
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
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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 |
| April 20, 2017 | VAI | 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 1012188 - 2017-04-20
- FDA Inspection 792624 - 2012-07-20
- FDA Inspection 637083 - 2009-12-04
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