FDA Inspection 1329546 — Louis M. Gerson Co., Inc.
The FDA completed an inspection of Louis M. Gerson Co., Inc. on Jul 24, 2026 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Middleboro, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23027 | ISO 13485:2016 Clause 4.1.6 | Procedures for validation of QMS software not documented |
| 23047 | ISO 13485:2016 Clause 4.2.5 | Changes to records not identifiable |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |