FDA Inspection
Delsam Pharma LLCDelsam Pharma LLC – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns Delsam Pharma LLC, with an inspection on March 24, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3ea42e68-9fb3-4b1a-93ca-2180b79b89f8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1200648
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
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