905650
J. Strickland and Co — FEI 1020294
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 26, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Olive Branch, MS (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |