Company
United StatesORCHID UNIQUE, Bridgeport, MI – FDA Inspections
Inspection records and compliance data for ORCHID UNIQUE in Bridgeport, Michigan. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 05, 2019.
Company Profile
This profile covers ORCHID UNIQUE based in Bridgeport, Michigan, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 1, 2017. Last inspected September 5, 2019.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces2 inspections
- Lack of or inadequate procedures2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1101178 |
| November 1, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1030456 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ORCHID UNIQUE
FEI Number
1828288
Address
6688 Dixie Hwy, Bridgeport, Michigan 48722, United States
Country
United States
ID: f3aa63a1-830f-4785-98b7-7b7196c15d27