FDA Inspection 641477 — Lincare Incorporated
The FDA completed an inspection of Lincare Incorporated on Jan 27, 2010 in West Hartford, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 27, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Hartford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |