FDA Inspection
I. Shay Cosmetics IncI. Shay Cosmetics Inc – FDA Inspection, Feb 21, 2012
Record Details
This FDA Inspection record concerns I. Shay Cosmetics Inc, with an inspection on February 21, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- I. Shay Cosmetics Inc
- Inspection Date
- February 21, 2012
- Product Type
- Drugs
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ID · 16022693-e98f-49da-b00a-991a7cd0844d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 769908
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 110.37(b)(5)Backflow prevention
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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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 |
| September 23, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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