FDA Inspection
I. Shay Cosmetics IncI. Shay Cosmetics Inc – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns I. Shay Cosmetics Inc, with an inspection on December 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 69ed1c98-475e-4e38-9a85-bf60295fc4a1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1034137
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.186(a)Master production and control records, batch uniformity
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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 |
| 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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