FDA Inspection
Innovative Chemical CorporationInnovative Chemical Corporation – FDA Inspection, Jan 27, 2009
Record Details
This FDA Inspection record concerns Innovative Chemical Corporation, with an inspection on January 27, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 27, 2009
- Product Type
- Drugs
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ID · 15c1f49e-e5cd-430b-b875-67396590d19f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554235
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.80(c)Storage off Floor, Spaced Suitably
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
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