FDA Inspection
International Pharmaceuticals, Inc.International Pharmaceuticals, Inc. – FDA Inspection, Jun 7, 2019
Record Details
This FDA Inspection record concerns International Pharmaceuticals, Inc., with an inspection on June 7, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 01b4b1dc-ab39-48cb-bcf4-31c35ad5a45a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092400
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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