Source: FDA, document on file. FDA 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 it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1000121499.
Observations8
Issue DateApril 12, 2017
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections3
Establishment Details
Firm
Mihalko Medical, LLC
Issued To
Hieber’s Pharmacy
Location
Pittsburgh, Pennsylvania, United States
FEI Number
1000121499
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
April 12, 2017
Country
United States
Inspection History, 2014 to 2019
VAI1
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.