FDA Inspection
Valmar Surgical Supplies, Inc.Valmar Surgical Supplies, Inc. – FDA Inspection, Jul 9, 2026
Record Details
This FDA Inspection record concerns Valmar Surgical Supplies, Inc., with an inspection on July 9, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- July 9, 2026
- Product Type
- Medical Devices & Rad Health
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ID · ab454a54-f14e-4cad-a8fd-e1c0c34f522b
Inspection Facts
- Inspection number
- 1325628
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.2.2Specific requirements of the Quality Manual not documented
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Valmar Surgical Supplies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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