FDA Inspection 675997 — 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 August 6, 2010 in Santa Fe Springs, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 42 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 6, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15752 | 21 CFR 111.210(c) | Master manufacturing record - components; weight, measure |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15775 | 21 CFR 111.415(e) | Dietary supplement containers - mix-ups |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15826 | 21 CFR 111.65 | Quality control - packaged, labeled |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 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 |
| 4576 | 21 CFR 211.192 | No written record of investigation |