FDA Inspection
Dr Sweat Institute for Atlas Orthogonal Chiropractic, LLCDr Sweat Institute for Atlas Orthogonal Chiropractic, LLC – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Dr Sweat Institute for Atlas Orthogonal Chiropractic, LLC, with an inspection on September 25, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
- Inspection Date
- September 25, 2026
- Product Type
- Medical Devices & Rad Health
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ID · b58a7a9a-fd80-4d65-b08b-ed07de91e91c
Inspection Facts
- Inspection number
- 1338768
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 8.2.6Evidence of conformity to the acceptance criteria not maintained
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Other FDA inspections of Dr Sweat Institute for Atlas Orthogonal Chiropractic, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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