FDA Inspection
S&S Primeline Chemical Systems, LLCS&S Primeline Chemical Systems, LLC – FDA Inspection, Oct 26, 2011
Record Details
This FDA Inspection record concerns S&S Primeline Chemical Systems, LLC, with an inspection on October 26, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 26, 2011
- Product Type
- Drugs
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ID · d8e29a70-dea2-4ffb-9439-cb38a463bca4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751568
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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