Company
United StatesZimVie US Corp LLC, Palm Beach Gardens, FL – FDA Inspections
Inspection records and compliance data for ZimVie US Corp LLC in Palm Beach Gardens, Florida. 6 FDA inspections on record (1 OAI), last inspected October 25, 2018.
Company Profile
This profile covers ZimVie US Corp LLC based in Palm Beach Gardens, Florida, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 1, 2009. Last inspected October 25, 2018.
Most cited issue areas
- Lack of or inadequate process validation3 inspections
- Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2018 | Not classified | Medical Devices & Rad Health | 1110361 |
| July 11, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1019545 |
| August 6, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 890687 |
| August 2, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 843868 |
| June 15, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 788665 |
| May 1, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 579982 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ZimVie US Corp LLC
FEI Number
1038806
Address
4555 Riverside Dr, Palm Beach Gardens, Florida 33410, United States
Country
United States
ID: c989df4d-fea7-4593-bb08-6a3362c62250