FDA Inspection
National Chemical LaboratoriesNational Chemical Laboratories – FDA Inspection, Nov 4, 2021
Record Details
This FDA Inspection record concerns National Chemical Laboratories, with an inspection on November 4, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 4, 2021
- Product Type
- Drugs
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ID · 1207d91e-d7bb-438f-9940-c34851d1b340
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1155946
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 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
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of National Chemical Laboratories
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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