FDA Inspection
Precision Align LLCPrecision Align LLC – FDA Inspection, Jul 20, 2023
Record Details
This FDA Inspection record concerns Precision Align LLC, with an inspection on July 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b956ebe3-9bbc-47a9-8c8b-df8a231a5324
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210466
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Precision Align LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
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