FDA Inspection 1087172 — Bay Shore Medical Equipment, LLC
The FDA completed an inspection of Bay Shore Medical Equipment, LLC on April 19, 2019 in Manorville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Manorville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |