Company
United StatesBlack Pearl Vision, Sarasota, FL – FDA Inspections
Inspection records and compliance data for Black Pearl Vision in Sarasota, Florida. 6 FDA inspections on record, last inspected April 11, 2024.
Company Profile
This profile covers Black Pearl Vision based in Sarasota, Florida, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected September 2, 2011. Last inspected April 11, 2024.
Most cited issue areas
- Design plans - Lack of or inadequate1 inspection
- Documentation1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 11, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1235862 |
| February 28, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1121945 |
| September 11, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 895035 |
| September 10, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 895034 |
| September 2, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 742766 |
| September 2, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 742764 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Black Pearl Vision
FEI Number
3005184723
Address
7455 16th St E Ste 108, Sarasota, Florida 34243, United States
Country
United States
ID: fe19e885-814b-4f78-8490-4a37133faa19