FDA Inspection
Perryman CompanyFDA Inspection 1307166 - Perryman Company - March 10, 2026
Record Details
This FDA Inspection record concerns Perryman Company, with an inspection on March 10, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.
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ID · 1728517d-3b78-4015-aedb-433f7fbaa9fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1307166
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 8.5.1Changes to maintain QMS and device not identified and implemented
- ISO 13485:2016 Clause 8.2.4Monitoring and measurement requirements of product characteristics are not met
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
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Other FDA inspections of Perryman Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Perryman Company
- FDA Inspection 1106963 - 2019-10-10
- FDA Inspection 1005622 - 2017-02-09
- FDA Inspection 941493 - 2015-09-10
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