FDA Inspection 978105 — Louis M. Gerson Co., Inc.
The FDA completed an inspection of Louis M. Gerson Co., Inc. on Jul 26, 2016 in Middleboro, MA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 26, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Middleboro, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |