FDA Inspection
Wellman Advanced Materials, LLCWellman Advanced Materials, LLC – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns Wellman Advanced Materials, LLC, with an inspection on December 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8b5dbee2-ec66-4766-ba84-368932459f9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074929
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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