Company
United StatesAMO Puerto Rico Manufacturing, Inc., Anasco, PR – FDA Inspections
Inspection records and compliance data for AMO Puerto Rico Manufacturing, Inc. in Anasco, Puerto Rico. 8 FDA inspections on record, 1 Form 483, last inspected October 05, 2018.
Company Profile
This profile covers AMO Puerto Rico Manufacturing, Inc. based in Anasco, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 6
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 1, 2009. Last inspected October 5, 2018.
Most cited issue areas
- Personnel requirements, Lack of or inadequate requirements2 inspections
- Corrective action taken1 inspection
- General1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 5, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1070384 |
| November 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 993515 |
| October 16, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 946268 |
| March 26, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 871503 |
| February 28, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 822723 |
| June 29, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 670573 |
| March 11, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 652088 |
| April 1, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 578657 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
AMO Puerto Rico Manufacturing, Inc.
FEI Number
2648035
Address
Rd # 402 North Km 4.2, Industrial Park, Anasco, Puerto Rico 00610, United States
Country
United States
ID: 705dc640-55d5-41d8-b558-d280ac5bc785