FDA Inspection
HTO Nevada IncHTO Nevada Inc – FDA Inspection, Aug 6, 2013
Record Details
This FDA Inspection record concerns HTO Nevada Inc, with an inspection on August 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HTO Nevada Inc
- Inspection Date
- August 6, 2013
- Product Type
- Drugs
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ID · eefe6dbc-cd24-495f-b214-f70e184d430f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841998
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.100(a)Absence of Written Procedures
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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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