FDA Inspection
Perma Laboratories LLCPerma Laboratories LLC – FDA Inspection, Aug 4, 2026
Record Details
This FDA Inspection record concerns Perma Laboratories LLC, with an inspection on August 4, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 92a1b192-8a28-48d2-9f20-72e540961ee2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1329294
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 7.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 4.1.6Equipment calibration or verification not performed
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 7.6Equipment calibration or verification not performed
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Other FDA inspections of Perma Laboratories LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 19, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Perma Laboratories LLC
- FDA Inspection 1055078 - 2018-06-08
- FDA Inspection 804595 - 2012-11-01
- FDA Inspection 750306 - 2011-10-19
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