FDA Inspection
Apex International Mfg., LLCApex International Mfg., LLC – FDA Inspection, Oct 31, 2017
Record Details
This FDA Inspection record concerns Apex International Mfg., LLC, with an inspection on October 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3b972dac-438a-4b53-b756-b6b665ded7f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030330
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Apex International Mfg., LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 11, 2023 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| August 4, 2015 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| January 27, 2015 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| March 31, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apex International Mfg., LLC
- FDA Inspection 1214939 - 2023-08-11
- FDA Inspection 1196639 - 2023-01-11
- FDA Inspection 937906 - 2015-08-04
- FDA Inspection 918226 - 2015-01-27
- FDA Inspection 715478 - 2011-03-31
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