FDA Inspection 1329546 - Louis M. Gerson Co., Inc. - July 24, 2026

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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.

Company: Louis M. Gerson Co., Inc.
Inspection Date: July 24, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 0c22917a-6539-436b-8ec3-96e8bcb35827

Violation Codes8

21 CFR 803ISO 13485:2016 Clause 4.1.3ISO 13485:2016 Clause 4.1.6ISO 13485:2016 Clause 4.2.5ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.3.10ISO 13485:2016 Clause 7.5.8ISO 13485:2016 Clause 8.2.2

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FDA Inspection

Louis M. Gerson Co., Inc.July 24, 2026