FDA Inspection
Grace Healthcare Medical, IncGrace Healthcare Medical, Inc – FDA Inspection, Aug 23, 2016
Record Details
This FDA Inspection record concerns Grace Healthcare Medical, Inc, with an inspection on August 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 23, 2016
- Product Type
- Drugs
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ID · ad4fad4d-b67f-421d-b928-998c9cee95f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983626
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.100(a)Approval and review of procedures
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