FDA Inspection
ABL Medical, LLCABL Medical, LLC – FDA Inspection, Jun 30, 2010
Record Details
This FDA Inspection record concerns ABL Medical, LLC, with an inspection on June 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ABL Medical, LLC
- Inspection Date
- June 30, 2010
- Product Type
- Devices
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ID · ce7c6d98-4c12-4ac7-9f7c-c9dca881e43f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671260
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 110.35(c)Lack of effective pest exclusion
- 21 CFR 110.20(b)(7)Screening
- 21 CFR 110.80(b)(8)Metal / extraneous materials
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
Showing 10 of 14 citations.
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Other FDA inspections of ABL Medical, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 30, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 30, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ABL Medical, LLC
- FDA Inspection 1194783 - 2023-01-10
- FDA Inspection 1053989 - 2018-05-30
- FDA Inspection 928095 - 2015-05-21
- FDA Inspection 797283 - 2012-08-30
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