FDA Inspection
Sarati International, IncSarati International, Inc – FDA Inspection, Jun 29, 2011
Record Details
This FDA Inspection record concerns Sarati International, Inc, with an inspection on June 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sarati International, Inc
- Inspection Date
- June 29, 2011
- Product Type
- Drugs
View Company Profile
ID · f8113aaa-f78e-4797-8483-93e9a798c74e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732571
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.42(c)Defined areas of adequate size for operations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sarati International, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2019 | Not classified | Dallas District Office | |
| June 30, 2017 | Not classified | Dallas District Office | |
| November 20, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 31, 2009 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Sarati International, Inc
- FDA Inspection 1256177 - 2025-03-21
- FDA Inspection 1093755 - 2019-06-13
- FDA Inspection 1021815 - 2017-06-30
- FDA Inspection 953924 - 2015-11-20
- FDA Inspection 613028 - 2009-08-31
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