FDA Inspection
GemdoGemdo – FDA Inspection, Feb 12, 2018
Record Details
This FDA Inspection record concerns Gemdo, with an inspection on February 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · dd5e6881-52fe-44f4-9155-357f6f782038
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040996
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gemdo
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2016 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| October 21, 2015 | OAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| December 23, 2014 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Gemdo
- FDA Inspection 952683 - 2016-01-25
- FDA Inspection 945759 - 2015-10-21
- FDA Inspection 906175 - 2014-12-23
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