FDA Inspection
Waltman Pharmaceuticals, Inc.Waltman Pharmaceuticals, Inc. – FDA Inspection, Aug 27, 2015
Record Details
This FDA Inspection record concerns Waltman Pharmaceuticals, Inc., with an inspection on August 27, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 27, 2015
- Product Type
- Drugs
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ID · bcab53b7-441d-4dc6-b56b-6ffc83e0b3af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940152
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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