FDA Inspection
Abbott LaboratoriesAbbott Laboratories – FDA Inspection, Aug 24, 2012
Record Details
This FDA Inspection record concerns Abbott Laboratories, with an inspection on August 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Laboratories
- Inspection Date
- August 24, 2012
- Product Type
- Devices
View Company Profile
ID · 4ee25676-a802-4ecb-858d-32f5e68d5031
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796961
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(2)Supplier oversight
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abbott Laboratories
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2019 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 14, 2018 | Not classified | Chicago District Office | |
| October 12, 2017 | Not classified | Chicago District Office | |
| March 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abbott Laboratories
- FDA Inspection 1090280 - 2019-03-27
- FDA Inspection 1123472 - 2018-09-14
- FDA Inspection 1038482 - 2017-10-12
- FDA Inspection 715413 - 2011-03-10
- FDA Inspection 675926 - 2010-07-27
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