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 3011581046.
Observations15
Issue DateSeptember 01, 2016
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections2
Establishment Details
Firm
Kalman Health & Wellness, Inc.
Location
Peoria, Illinois, United States
FEI Number
3011581046
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
September 01, 2016
Country
United States
Inspection History, 2015 to 2018
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.