FDA Inspection
Grafor, Inc.Grafor, Inc. – FDA Inspection, May 6, 2016
Record Details
This FDA Inspection record concerns Grafor, Inc., with an inspection on May 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Grafor, Inc.
- Inspection Date
- May 6, 2016
- Product Type
- Drugs
View Company Profile
ID · 0e8d0f2c-76fa-4c54-95a7-62e8e7f90c2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969527
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.67(b)Written procedures fail to include
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