FDA Inspection
Prime PackagingPrime Packaging – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns Prime Packaging, with an inspection on July 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 72ee8bc1-9ab6-4b30-9201-216ef989dc89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095984
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.122(a)Written procedures describing in detail
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Prime Packaging
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| April 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 4, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 8, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Prime Packaging
- FDA Inspection 1277276 - 2025-08-01
- FDA Inspection 881383 - 2014-04-29
- FDA Inspection 760406 - 2012-01-04
- FDA Inspection 594187 - 2009-06-08
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