American Specialty Pharmacy, Inc. dba ASP Cares
FDA issued a warning letter to American Specialty Pharmacy, Inc. dba ASP Cares (Farmers Branch, TX), an outsourcing facility registered under section 503B of the FDCA, following a 2018 inspection that revealed serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility produced adulterated drug products due to insanitary conditions and CGMP violations including inadequate smoke studies, deficient media fills, facility disrepair, and failure to document pressure differentials. Because the facility failed to comply with adverse event reporting requirements under 503B(b)(5), its compounded products lost eligibility for exemptions from FDA approval, adequate-directions-for-use labeling, and Drug Supply Chain Security Act requirements, rendering them unapproved new drugs and misbranded products. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (7)
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
Your firm's facilities where sterile drug production occurs is not maintained in an adequate state of repair. For example, the investigator noted a crack in the caulking around the HEPA filter inside the ISO 7 cleanroom ante of Modular 1.
Your firm failed to document and measure pressure differentials during operations to demonstrate proper airflow.
Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
Your media fills were not performed under the most challenging or stressful conditions such as failing to simulate the largest batch size produced at your firm.
Your documented procedures do not adequately define what constitutes a serious adverse event or unexpected adverse event.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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