FDA Inspection
Gotha Cosmetics SrlGotha Cosmetics Srl – FDA Inspection, Mar 1, 2024
Record Details
This FDA Inspection record concerns Gotha Cosmetics Srl, with an inspection on March 1, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 48f42bda-4844-4d00-bbc5-967efd977e8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232699
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Gotha Cosmetics Srl
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Gotha Cosmetics Srl
- FDA Inspection 1035096 - 2017-09-22
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