FDA Inspection
Graxcell USA, LLCGraxcell USA, LLC – FDA Inspection, Nov 5, 2018
Record Details
This FDA Inspection record concerns Graxcell USA, LLC, with an inspection on November 5, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Jay T. Wong (Issuing Officer)
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ID · 6fc5028a-2213-4195-a0b4-08960ef6df28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070902
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.67(b)Written procedures not established/followed
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