FDA Inspection 885391 — Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs
The FDA completed an inspection of Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs on June 16, 2014 in Santa Fe Springs, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15908 | 21 CFR 111.90(b)(1) | Reprocessed, dietary supplement - no material review |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |