FDA Inspection 897322 — Keystone Laboratories, Inc.
The FDA completed an inspection of Keystone Laboratories, Inc. on September 12, 2014 in Memphis, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |