FDA Inspection
ATS Manufacturing LLC.ATS Manufacturing LLC. – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns ATS Manufacturing LLC., with an inspection on August 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d4ce11bb-e57c-4701-bbc8-f7fa75e959c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023270
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ATS Manufacturing LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ATS Manufacturing LLC.
- FDA Inspection 783646 - 2012-05-25
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