FDA Inspection 784467 — Mission Pharmacal Company
The FDA completed an inspection of Mission Pharmacal Company on May 25, 2012 in Boerne, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 25, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boerne, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |