FDA Inspection
Reese Pharmaceutical CompanyReese Pharmaceutical Company – FDA Inspection, Nov 24, 2010
Record Details
This FDA Inspection record concerns Reese Pharmaceutical Company, with an inspection on November 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Reese Pharmaceutical Company
- Inspection Date
- November 24, 2010
- Product Type
- Drugs
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ID · c38ba460-7d5d-4a11-9b53-72a375e880e5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 697501
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 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 211.196Distribution Record Requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
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Other FDA inspections of Reese Pharmaceutical Company
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2025 | Not classified | Cincinnati District Office | |
| December 9, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 8, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 5, 2017 | NAI | Center for Food Safety and Applied Nutrition | Pesticides and Chemical Contaminants |
| April 25, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Reese Pharmaceutical Company
- FDA Inspection 1287906 - 2025-09-25
- FDA Inspection 1160702 - 2021-12-09
- FDA Inspection 1160701 - 2021-12-08
- FDA Inspection 1017672 - 2017-06-05
- FDA Inspection 1012578 - 2017-04-25
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