FDA Inspection 803533 — Florida Palliative Equipment L.L.C.
The FDA completed an inspection of Florida Palliative Equipment L.L.C. on Oct 19, 2012 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |