FDA Inspection
Associates CreativeAssociates Creative – FDA Inspection, Sep 14, 2011
Record Details
This FDA Inspection record concerns Associates Creative, with an inspection on September 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Associates Creative
- Inspection Date
- September 14, 2011
- Product Type
- Drugs
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ID · d1ad8b8e-c58b-4d22-aa54-368e96663279
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745358
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.103Written procedures - quality control operations
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