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FDA Inspection
•Positive Promotions•February 7, 2025

Positive Promotions – FDA Inspection, Feb 7, 2025

Record Details

This FDA Inspection record concerns Positive Promotions, with an inspection on February 7, 2025, issued by the New York District Office, covering human drugs.

Company
Positive Promotions
Inspection Date
February 7, 2025
Product Type
Human Drugs
Office
New York District Office
Person
  • Gam S. Zamil (Company Rep)
View Company Profile

ID · a8feaa8d-3d39-4d2e-805d-902ae4b98fdc

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1260232
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

5
  1. 21 CFR 211.25(a)GMP Training Frequency
  2. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  3. 21 CFR 211.188(b)(2)Identification of Equipment and Lines
  4. 21 CFR 211.22(d)Procedures not in writing, fully followed
  5. 21 CFR 211.100(a)Absence of Written Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Positive Promotions

1
DateClassificationOfficeProject area
April 25, 2022OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Positive Promotions
  • FDA Inspection 1167870 - 2022-04-25

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