FDA Inspection
Materials Analytical Services LLCMaterials Analytical Services LLC – FDA Inspection, Nov 13, 2017
Record Details
This FDA Inspection record concerns Materials Analytical Services LLC, with an inspection on November 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7cd7f7d8-fd01-4b52-98b9-32dacaefbf4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031954
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.42(c)(9)Control / Lab Operations Area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.80(a)Written Procedures Not Followed
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