FDA Inspection
Simpex Pharma Pvt. LtdSimpex Pharma Pvt. Ltd – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns Simpex Pharma Pvt. Ltd, with an inspection on March 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 49726c86-9c4b-4bdf-bc49-746326d23e9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042607
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 111.16Written procedures - pest control
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