Source: FDA, document on fileFDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it.
To check this against FDA, open FDA's record for this establishment on FDA's Data Dashboard, which lists this inspection under FEI 3002498892.
Theken Companies LLC
Akron, Ohio, United States
Issue DateJuly 11, 2015
FEI Number3002498892
CountryUnited States
Status
No Warning Letter
Product Type
Devices
Establishment Type
Medical Device Manufacturer
Theken Companies LLC FDA Form 483, Akron, Ohio, July 11, 2015
