FDA Inspection 748946 — Medical Equipment And Supplies Of America, LLC
The FDA completed an inspection of Medical Equipment And Supplies Of America, LLC on Oct 6, 2011 in Saint Petersburg, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 6, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |