FDA Inspection
Premier Cosmetic Laboratories Holding LLCPremier Cosmetic Laboratories Holding LLC – FDA Inspection, Dec 9, 2009
Record Details
This FDA Inspection record concerns Premier Cosmetic Laboratories Holding LLC, with an inspection on December 9, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 9, 2009
- Product Type
- Drugs
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ID · 63f12406-527b-4bf7-88d2-d8e489d4ac40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 633324
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
23- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
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