FDA Inspection
I. Shay Cosmetics IncI. Shay Cosmetics Inc – FDA Inspection, Sep 20, 2021
Record Details
This FDA Inspection record concerns I. Shay Cosmetics Inc, with an inspection on September 20, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- I. Shay Cosmetics Inc
- Inspection Date
- September 20, 2021
- Product Type
- Drugs
View Company Profile
ID · 58515850-4e40-4777-9200-3ba3c95fd4e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1153711
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| September 23, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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