FDA Inspection
Health-Chem Acquisitions, LLCHealth-Chem Acquisitions, LLC – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Health-Chem Acquisitions, LLC, with an inspection on February 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fcf030e6-26da-401a-b2ea-dd9b15a4f221
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000589
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Health-Chem Acquisitions, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 27, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Health-Chem Acquisitions, LLC
- FDA Inspection 1079912 - 2019-02-20
- FDA Inspection 881602 - 2014-06-03
- FDA Inspection 788542 - 2012-09-27
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