FDA Inspection
Penniman & Browne, Inc.Penniman & Browne, Inc. – FDA Inspection, Jul 9, 2010
Record Details
This FDA Inspection record concerns Penniman & Browne, Inc., with an inspection on July 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Penniman & Browne, Inc.
- Inspection Date
- July 9, 2010
- Product Type
- Drugs
View Company Profile
ID · f515b0d3-cf62-45dd-a37c-9df9cd4106a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671018
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 820.70(g)(1)Activity documentation
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(b)SOPs not followed / documented
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