Company
United StatesPhysician Engineered Products, Inc., Fryeburg, ME – FDA Inspections
Inspection records and compliance data for Physician Engineered Products, Inc. in Fryeburg, Maine. 4 FDA inspections on record, last inspected October 20, 2017.
Company Profile
This profile covers Physician Engineered Products, Inc. based in Fryeburg, Maine, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected October 9, 2008. Last inspected October 20, 2017.
Most cited issue areas
- Design validation - simulated testing1 inspection
- DHR - not or inadequately maintained1 inspection
- Quality Audit/Reaudit - conducted1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 20, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1032554 |
| June 23, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 936480 |
| December 21, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 759924 |
| October 9, 2008 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 542242 |
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
Physician Engineered Products, Inc.
FEI Number
2183604
Address
103 Smith St, Fryeburg, Maine 04037, United States
Country
United States
ID: 5a2db33f-7980-486a-bb33-bcdcde89e97f