Date:
Wed, 27 May 2026 12:27:53 EDT
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 for Wells Pharma of Houston LLC, an outsourcing facility based in Houston, Texas. The document follows an agency inspection conducted in April 2026 to evaluate the firm’s compliance with federal manufacturing standards.
A Form 483 is issued by FDA investigators when they observe conditions that may constitute violations of the Food, Drug, and Cosmetic Act. For outsourcing facilities, these inspections focus on Current Good Manufacturing Practice (CGMP) requirements to ensure that compounded medications are produced under sterile and safe conditions.
The issuance of this report serves as a formal notification of observed concerns, providing the company an opportunity to address and correct the findings. The FDA maintains oversight of such facilities to mitigate risks associated with compounded drugs and to protect patient safety.
Source: FDA Electronic Reading Room
Link:
http://www.fda.gov/about-fda/fda-commissioner/wells-pharma-houston-llc-houston-tx-483-issued-4132026
Keywords:
FDA, Wells Pharma of Houston LLC, Form 483, Outsourcing Facility, Drug Safety, Inspection, Texas