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FDA Inspection
•Prime Packaging•August 1, 2025

Prime Packaging – FDA Inspection, Aug 1, 2025

Record Details

This FDA Inspection record concerns Prime Packaging, with an inspection on August 1, 2025, issued by the Florida District Office, covering human drugs.

Company
Prime Packaging
Inspection Date
August 1, 2025
Product Type
Human Drugs
Office
Florida District Office
People
  • Kara J. Wright
  • Vivin George (Investigator)
View Company Profile

ID · 156bf089-237a-496b-9440-88a63a077b5c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1277276
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

5
  1. 21 CFR 211.142(b)Storage under appropriate conditions
  2. 21 CFR 211.63Equipment Design, Size and Location
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed
  4. 21 CFR 211.42(c)Defined areas of adequate size for operations
  5. 21 CFR 211.100(a)Absence of Written Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Prime Packaging

4
DateClassificationOfficeProject area
July 12, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 29, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 4, 2012NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
June 8, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Prime Packaging
  • FDA Inspection 1095984 - 2019-07-12
  • FDA Inspection 881383 - 2014-04-29
  • FDA Inspection 760406 - 2012-01-04
  • FDA Inspection 594187 - 2009-06-08

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