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FDA Inspection
•Neoteric Cosmetics, Incorporated•July 9, 2009

Neoteric Cosmetics, Incorporated – FDA Inspection, Jul 9, 2009

Record Details

This FDA Inspection record concerns Neoteric Cosmetics, Incorporated, with an inspection on July 9, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Neoteric Cosmetics, Incorporated
Inspection Date
July 9, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 8250d084-0e76-4497-bf6c-93c9643b6d8c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
583459
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

12
  1. 21 CFR 211.166(b)Adequate number of batches on stability
  2. 21 CFR 211.150(b)Recall facilitation
  3. 21 CFR 211.192Quality control unit review of records
  4. 21 CFR 211.137(a)Expiration date lacking
  5. 21 CFR 211.25(a)Training , Education , Experience overall
  6. 21 CFR 211.110(b)In-process materials specifications
  7. 21 CFR 211.160(b)Scientifically sound laboratory controls
  8. 21 CFR 211.204Record information maintained
  9. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  10. 21 CFR 211.165(a)Testing and release for distribution

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Neoteric Cosmetics, Incorporated

2
DateClassificationOfficeProject area
November 19, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 7, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Neoteric Cosmetics, Incorporated
  • FDA Inspection 904026 - 2014-11-19
  • FDA Inspection 712386 - 2011-03-07

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