FDA Inspection 610572 — Visionary Medical Supplies Inc.
The FDA completed an inspection of Visionary Medical Supplies Inc. on September 8, 2009 in Madison, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Madison, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3144 | 21 CFR 820.160(a) | Control/distribution procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3316 | 21 CFR 820.160(a) | Expired or deteriorated devices |
| 3699 | 21 CFR 820.160(b) | Distribution records |