FDA Inspection 681922 — Medicor Homecare, Inc.
The FDA completed an inspection of Medicor Homecare, Inc. on Sep 23, 2010 in Tampa, 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |