FDA Inspection
I. Shay Cosmetics IncI. Shay Cosmetics Inc – FDA Inspection, Sep 24, 2009
Record Details
This FDA Inspection record concerns I. Shay Cosmetics Inc, with an inspection on September 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- I. Shay Cosmetics Inc
- Inspection Date
- September 24, 2009
- Product Type
- Drugs
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ID · f2e73024-bf52-476a-bb66-34341fa6b624
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615932
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of I. Shay Cosmetics Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| September 20, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2013 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 21, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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