FDA Inspection
Whitehill Manufacturing IncWhitehill Manufacturing Inc – FDA Inspection, Jan 20, 2016
Record Details
This FDA Inspection record concerns Whitehill Manufacturing Inc, with an inspection on January 20, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Whitehill Manufacturing Inc
- Inspection Date
- January 20, 2016
- Product Type
- Drugs
View Company Profile
ID · c24d38b3-a64e-4f23-8fd9-5f8bd43af552
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958731
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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