Company
United StatesAbbott Medical, Arecibo, PR – FDA Inspections
Inspection records and compliance data for Abbott Medical in Arecibo, Puerto Rico. 8 FDA inspections on record, 1 Form 483, last inspected November 23, 2022.
Company Profile
This profile covers Abbott Medical based in Arecibo, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 5
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 24, 2010. Last inspected November 23, 2022.
Most cited issue areas
- Documentation2 inspections
- Equipment Installation, Placement, Specified Requirements1 inspection
- Supplier notification of changes1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 23, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1191919 |
| June 8, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1062742 |
| March 2, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1043177 |
| June 3, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 936355 |
| April 11, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 874498 |
| May 7, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 832020 |
| October 2, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 802088 |
| June 24, 2010 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 669519 |
FDA documents
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Company Information
Name
Abbott Medical
FEI Number
3006705815
Address
Lot A Interior -Carr #2 Km 67.5, Santana Indl. Park, Sector Los Pinos, Arecibo, Puerto Rico 00613, United States
Country
United States
ID: 5402bde4-6e65-429a-b770-28a7f6e13f26