Company
United StatesPinook USA, LLC, Orlando, FL – FDA Inspections
Inspection records and compliance data for Pinook USA, LLC in Orlando, Florida. 4 FDA inspections on record (4 OAI), last inspected May 13, 2015.
Company Profile
This profile covers Pinook USA, LLC based in Orlando, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 4
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected February 24, 2012. Last inspected May 13, 2015.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 13, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 927022 |
| December 2, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 904825 |
| March 1, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 821133 |
| February 24, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 769446 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Pinook USA, LLC
FEI Number
3008113239
Address
11374 Space Blvd, Orlando, Florida 32837, United States
Country
United States
ID: 49affed3-010f-4eee-9b84-2e376ee9dd64