FDA Inspection
Sun Dental Laboratories, LLCSun Dental Laboratories, LLC – FDA Inspection, Apr 1, 2026
Record Details
This FDA Inspection record concerns Sun Dental Laboratories, LLC, with an inspection on April 1, 2026, issued by the Florida District Office, covering medical devices & rad health.
- Company
- Sun Dental Laboratories, LLC
- Inspection Date
- April 1, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 2971b701-e7ec-498d-9f8f-0c9f3241856b
Inspection Facts
- Inspection number
- 1310438
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued, view the record
FDA Citations
8- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.3QMS processes not adequate
- ISO 13485:2016 Clause 7.1Required elements not determined in planning product realization
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- 21 CFR 820.35(c)UDI was not recorded for each medical device or batch
- ISO 13485:2016 Clause 5.1Lack of evidence for top management's commitment to QMS
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sun Dental Laboratories, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sun Dental Laboratories, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.