FDA Inspection 720021 — TCA Cellular Therapy, LLC
The FDA completed an inspection of TCA Cellular Therapy, LLC on March 31, 2011 in Covington, LA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 37 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Covington, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12279 | 21 CFR 1271.75(b) | Risk factors, leukocyte-rich cells or tissues |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 15025 | 21 CFR 1271.85(b)(2) | Cytomegalovirus (CMV) |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7635 | 21 CFR 312.7(b) | Commercial distribution of an investigational drug |
| 7636 | 21 CFR 312.8(a)(3) | Charging for Investigational Drugs Under IND |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |