FDA Inspection
Apex International Mfg., LLCApex International Mfg., LLC – FDA Inspection, Mar 31, 2011
Record Details
This FDA Inspection record concerns Apex International Mfg., LLC, with an inspection on March 31, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Apex International Mfg., LLC
- Inspection Date
- March 31, 2011
- Product Type
- Drugs
View Company Profile
ID · ab46ade2-74f8-47c4-9941-82a17e73cfea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715478
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.80(a)Procedures To Be in Writing
Full citation text and observation details available on the Dashboard.
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 |
| October 31, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
Other documents for Apex International Mfg., LLC
- FDA Inspection 1214939 - 2023-08-11
- FDA Inspection 1196639 - 2023-01-11
- FDA Inspection 1030330 - 2017-10-31
- FDA Inspection 937906 - 2015-08-04
- FDA Inspection 918226 - 2015-01-27
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