Company
United StatesCEP Bio-Coat, LLC, Farmington Hills, MI – FDA Inspections
Inspection records and compliance data for CEP Bio-Coat, LLC in Farmington Hills, Michigan. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected October 12, 2022.
Company Profile
This profile covers CEP Bio-Coat, LLC based in Farmington Hills, Michigan, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 16, 2009. Last inspected October 12, 2022.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Nonconforming product, Lack of or inadequate procedures3 inspections
- Lack/Inad procedure-Monitoring/Control of Validated Proces2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 12, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1181581 |
| September 29, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1130392 |
| February 15, 2019 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1079579 |
| March 10, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 962624 |
| April 26, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 783377 |
| July 16, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 599786 |
FDA documents
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Company Information
Name
CEP Bio-Coat, LLC
FEI Number
3011277306
Address
23149 Commerce Dr, Farmington Hills, Michigan 48335, United States
Country
United States
ID: 3f1e2dce-40c6-4608-94a6-1955bfe593b9