FDA Inspection
Legacy Pharmaceuticals Switzerland GmbHLegacy Pharmaceuticals Switzerland GmbH – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Legacy Pharmaceuticals Switzerland GmbH, with an inspection on July 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d687ff6c-8625-4830-98d4-e5a2f1f54816
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018900
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Legacy Pharmaceuticals Switzerland GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Legacy Pharmaceuticals Switzerland GmbH
- FDA Inspection 661172 - 2010-03-30
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