FDA Inspection
Grander Acquisition LLCGrander Acquisition LLC – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns Grander Acquisition LLC, with an inspection on July 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 2386eca8-71eb-44ea-ac72-c127c7c719e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058841
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
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