FDA Inspection 597192 — Keystone Laboratories, Inc.
The FDA completed an inspection of Keystone Laboratories, Inc. on July 1, 2009 in Memphis, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 1, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Memphis, TN (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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |