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 3016710931.
Observations3
Issue DateDecember 14, 2022
Status1 Related Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections3
Establishment Details
Firm
Wells Pharma of Houston LLC
Location
Houston, Texas, United States
FEI Number
3016710931
Establishment Type
Outsourcing Facility
Product Type
Drugs
Issue Date
December 14, 2022
Country
United States
Inspection History, 2021 to 2025
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.