Company
United StatesPentax of America Inc, Montvale, NJ – FDA Inspections
Inspection records and compliance data for Pentax of America Inc in Montvale, New Jersey. 7 FDA inspections on record (2 OAI), 1 Form 483, last inspected July 20, 2023.
Company Profile
This profile covers Pentax of America Inc based in Montvale, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 18, 2009. Last inspected July 20, 2023.
Most cited issue areas
- Complaints1 inspection
- Documentation1 inspection
- Document review, approval by designated individual1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1211451 |
| September 27, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1066901 |
| April 2, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 921077 |
| December 17, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 906155 |
| December 18, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 812553 |
| March 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 718354 |
| May 18, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 583525 |
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
Pentax of America Inc
FEI Number
1000080301
Address
3 Paragon Dr, Montvale, New Jersey 07645, United States
Country
United States
ID: 4a00a7fe-b951-46eb-8a88-2842b89a05ad