FDA Inspection 703135 — BENEV Company Inc
The FDA completed an inspection of BENEV Company Inc on December 14, 2010 in Mission Viejo, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 14, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mission Viejo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3555 | 21 CFR 211.48(b) | Drains--Size, Back-siphonage Prevention |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |