FDA Inspection
Missouri Vocational EnterpriseMissouri Vocational Enterprise – FDA Inspection, Nov 23, 2008
Record Details
This FDA Inspection record concerns Missouri Vocational Enterprise, with an inspection on November 23, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 23, 2008
- Product Type
- Drugs
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ID · 030fe292-9f50-4ee6-b171-bba555d487a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566296
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
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