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 3014229024.
Observations1
Issue DateSeptember 05, 2025
Status1 Related Warning Letter
Establishment TypeProducer of Sterile and Non Sterile Drug Products
Related Inspections2
Establishment Details
Firm
North American Custom Laboratories LLC
Location
Richardson, Texas, United States
FEI Number
3014229024
Establishment Type
Producer of Sterile and Non Sterile Drug Products
Product Type
Drugs
Issue Date
September 05, 2025
Country
United States
Inspection History, 2022 to 2025
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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