FDA Inspection
Cerno PharmaceuticalCerno Pharmaceutical – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Cerno Pharmaceutical, with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 908172df-c82a-415b-a290-1dd1101f4336
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1031540
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.101(c)(1)Q.C. release check by second individual
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.182Written records kept in individual logs
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