FDA Inspection
Keystone IndustriesKeystone Industries – FDA Inspection, Jul 25, 2025
Record Details
This FDA Inspection record concerns Keystone Industries, with an inspection on July 25, 2025, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · aa92c0d2-ec87-40fe-9e02-f108cf18e784
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1277645
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Keystone Industries
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Keystone Industries
- FDA Inspection 1201036 - 2022-11-17
- FDA Inspection 763185 - 2012-01-23
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