FDA Inspection 769056 — Physicians Total Care, Inc.
The FDA completed an inspection of Physicians Total Care, Inc. on February 24, 2012 in Tulsa, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 24, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tulsa, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |