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 3013444075.
Observations2
Issue DateSeptember 15, 2017
Status1 Related Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections2
Establishment Details
Firm
Custom RX LLC
Location
Wichita, Kansas, United States
FEI Number
3013444075
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
September 15, 2017
Country
United States
Inspection History, 2017 to 2021
NAI1
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.