FDA Inspection
HTO Nevada IncHTO Nevada Inc – FDA Inspection, Nov 22, 2011
Record Details
This FDA Inspection record concerns HTO Nevada Inc, with an inspection on November 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HTO Nevada Inc
- Inspection Date
- November 22, 2011
- Product Type
- Drugs
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ID · 9eca35a0-c45b-4fec-987f-75dc9a507901
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754493
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of HTO Nevada Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | OAI | Seattle District Office | Drug Quality Assurance |
| August 17, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 2, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 14, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for HTO Nevada Inc
- FDA Inspection 1279218 - 2025-08-22
- FDA Inspection 1216435 - 2023-08-17
- FDA Inspection 1083505 - 2019-03-15
- FDA Inspection 1065834 - 2018-04-02
- FDA Inspection 1010178 - 2017-04-14
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