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 1000121499.
Mihalko Medical, LLC
Pittsburgh, Pennsylvania, United States
Issue DateJuly 23, 2015
FEI Number1000121499
CountryUnited States
Status
No Warning Letter
Product Type
Drugs
Establishment Type
Producer of Sterile Drug Products
Mihalko Medical, LLC FDA Form 483, Pittsburgh, Pennsylvania, July 23, 2015