FDA WARNING_LETTER - Westlab Pharmacy, Inc. dba Westlab Pharmacy - August 15, 2018

The FDA inspected Westlab Pharmacy, Inc. from August 6-15, 2018, identifying serious deficiencies in sterile drug production and violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm failed to meet Section 503A conditions for exemption from CGMP, labeling, and FDA approval, specifically by compounding non-sterile drug products without individually-identified patient prescriptions (e.g., for office stock).

Violations included adulterated drug products due to insanitary conditions: an ISO 5 compounding aseptic containment isolator (CACI) in a non-cleanroom, use of non-sterile cleaning agents/wipes in an ISO 5 laminar airflow workstation (LAFW), exposed hands during aseptic processing, an uncovered light fixture in the ISO 5 area, and continued production in an ISO 5 LAFW after microbial contamination. Additionally, non-pharmaceutical grade components (e.g., drinking alcohol) were used for injectables, and water quality for non-sterile products was not confirmed.

The firm also violated CGMP regulations (21 CFR Parts 210 and 211) by failing to establish written procedures for component handling, conduct final product testing for identity and strength, and support expiration dates with stability testing. These issues render the ineligible drug products adulterated and misbranded under FDCA Sections 501(a)(2)(A), 501(a)(2)(