FDA Inspection 601990 — Truett Laboratories, Inc.
The FDA completed an inspection of Truett Laboratories, Inc. on July 6, 2009 in Azusa, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 40 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 6, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Azusa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1293 | 21 CFR 110.20(b)(2) | Contamination with microorganisms, chemicals, filth, etc. |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2022 | 21 CFR 211.188(b)(10) | Documentation of Sampling Performed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 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 |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 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. |
| 4367 | 21 CFR 211.188(b)(13) | Examinations for correct labeling |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |