FDA Inspection
CRB S.A.CRB S.A. – FDA Inspection, Dec 13, 2013
Record Details
This FDA Inspection record concerns CRB S.A., with an inspection on December 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CRB S.A.
- Inspection Date
- December 13, 2013
- Product Type
- Drugs
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ID · cd24b867-e718-4ff8-85b4-68c60b464bbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858529
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.44Adequate lighting not provided
- 21 CFR 211.46(a)Adequate ventilation not provided
- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.28(a)Protective Apparel Not Worn
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