FDA Inspection
PAR Formulations Private LimitedFDA Inspection 1224703 - PAR Formulations Private Limited - December 08, 2023
Record Details
This FDA Inspection record concerns PAR Formulations Private Limited, with an inspection on December 8, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5f63bbb1-e166-4b01-82cc-8952bf004f5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224703
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(b)Computer control of master formula records
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