FDA Inspection
Louis M. Gerson Co., Inc.Louis M. Gerson Co., Inc. – FDA Inspection, Jul 24, 2026
Record Details
This FDA Inspection record concerns Louis M. Gerson Co., Inc., with an inspection on July 24, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e75646e8-fa91-4c42-be20-dac95d80882a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1329546
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 803Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.5.8Procedures for validation of processes not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 7.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 4.1.3Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.10Design and development procedures not documented
- ISO 13485:2016 Clause 4.2.5Changes to records not identifiable
- ISO 13485:2016 Clause 4.1.6Procedures for validation of QMS software not documented
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- 21 CFR 803.17Lack of Written MDR Procedures
Showing 10 of 14 citations.
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Other FDA inspections of Louis M. Gerson Co., Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Louis M. Gerson Co., Inc.
- FDA Inspection 978105 - 2016-07-26
- FDA Inspection 773444 - 2012-03-14
- FDA Inspection 556184 - 2008-11-20
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