FDA Inspection
Star Health & Beauty LLCStar Health & Beauty LLC – FDA Inspection, Oct 26, 2016
Record Details
This FDA Inspection record concerns Star Health & Beauty LLC, with an inspection on October 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ab2f8bb8-e32d-434a-a029-c83f3ea7b5f7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 992252
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
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Other FDA inspections of Star Health & Beauty LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2020 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 19, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Star Health & Beauty LLC
- FDA Inspection 1123466 - 2020-03-16
- FDA Inspection 1071123 - 2018-09-19
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