FDA Inspection 616277 — BENEV Company Inc
The FDA completed an inspection of BENEV Company Inc on September 30, 2009 in Mission Viejo, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 25 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 30, 2009
- Fiscal Year
- 2009
- 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 |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 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 |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4576 | 21 CFR 211.192 | No written record of investigation |