FDA Inspection
Mission Pharmacal CompanyMission Pharmacal Company – FDA Inspection, May 25, 2012
Record Details
This FDA Inspection record concerns Mission Pharmacal Company, with an inspection on May 25, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mission Pharmacal Company
- Inspection Date
- May 25, 2012
- Product Type
- Drugs
View Company Profile
ID · 82b80392-9795-425b-8e61-d3c0f9805ef8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 784467
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Mission Pharmacal Company
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 4, 2019 | VAI | Dallas District Office | New Drug Evaluation |
| September 20, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 4, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mission Pharmacal Company
- FDA Inspection 1219105 - 2023-06-27
- FDA Inspection 1180935 - 2022-09-22
- FDA Inspection 1085124 - 2019-04-04
- FDA Inspection 1067651 - 2018-09-20
- FDA Inspection 1019109 - 2017-05-04
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