Company
United StatesCustomed, Inc., Fajardo, PR – FDA Inspections
Inspection records and compliance data for Customed, Inc. in Fajardo, Puerto Rico. 9 FDA inspections on record (2 OAI), 3 Form 483s, 1 warning letter, last inspected October 04, 2024.
Company Profile
This profile covers Customed, Inc. based in Fajardo, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 2
- VAI
- 2
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected May 13, 2009. Last inspected October 4, 2024.
Most cited issue areas
- Lack of or inadequate final acceptance procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Packaging2 inspections
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 4, 2024 | Not classified | Medical Devices & Rad Health | 1241487 |
| April 18, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1202831 |
| September 30, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1107809 |
| September 21, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1068203 |
| August 31, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 991316 |
| April 29, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 925953 |
| July 31, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 890465 |
| May 13, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 666797 |
| May 13, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 590156 |
FDA documents
Warning Letters (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Customed, Inc.
FEI Number
2648727
Address
Calle Igualdad Final #7, Fajardo, Puerto Rico 00738, United States
Country
United States
ID: 1b2cbb33-6103-4c40-827f-e944ed2f56b2