FDA Inspection
All Quality & Services, Inc.All Quality & Services, Inc. – FDA Inspection, Apr 10, 2026
Record Details
This FDA Inspection record concerns All Quality & Services, Inc., with an inspection on April 10, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b983dc30-74ad-48b8-881e-4b9ac04ee561
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1311782
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 5.6.1Management review records not maintained
- ISO 13485:2016 Clause 6.2(a)Process(es) for personnel competence, training and awareness not documented
- ISO 13485:2016 Clause 5.6.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 6.2Process(es) for personnel competence, training and awareness not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of All Quality & Services, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 9, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for All Quality & Services, Inc.
- FDA Inspection 1040164 - 2018-02-01
- FDA Inspection 922284 - 2015-04-09
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