FDA Inspection 727470 — 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, 2011 in Santa Fe Springs, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 40 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15469 | 21 CFR 111.20(c)(3) | Physical plant - separate areas for products |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4416 | 21 CFR 211.204 | Reprocessed returned drug products |
| 4576 | 21 CFR 211.192 | No written record of investigation |