FDA Inspection 750099 — Florida Palliative Equipment L.L.C.
The FDA completed an inspection of Florida Palliative Equipment L.L.C. on Oct 21, 2011 in Ocala, FL. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2572 | 21 CFR 211.198(b) | Complaint File Location |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4327 | 21 CFR 211.122(c) | Records fail to include |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |