FDA Inspection
Warner Graham LLLPWarner Graham LLLP – FDA Inspection, May 21, 2024
Record Details
This FDA Inspection record concerns Warner Graham LLLP, with an inspection on May 21, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3fa427f2-53b8-4cf6-8b0c-a65b78e71cc0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240391
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Warner Graham LLLP
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Warner Graham LLLP
- FDA Inspection 984367 - 2016-09-09
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