FDA Inspection
Folsom Metal Products, Inc.Folsom Metal Products, Inc. – FDA Inspection, Aug 9, 2024
Record Details
This FDA Inspection record concerns Folsom Metal Products, Inc., with an inspection on August 9, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · af9b1153-ca4f-4970-b9b7-1143f7d17ae0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1247616
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
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Other FDA inspections of Folsom Metal Products, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | VAI | New Orleans District Office | Compliance: Medical Devices |
| February 8, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 13, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 3, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Folsom Metal Products, Inc.
- FDA Inspection 1277858 - 2025-08-01
- FDA Inspection 1162055 - 2022-02-08
- FDA Inspection 1041064 - 2017-11-13
- FDA Inspection 991771 - 2016-10-17
- FDA Inspection 870523 - 2014-03-03
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