FDA Inspection 758746 — Applied Consumer Services Inc.
The FDA completed an inspection of Applied Consumer Services Inc. on January 6, 2012 in Hialeah Gardens, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 6, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Hialeah Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |