FDA WARNING_LETTER - Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy - April 05, 2019

On January 13, 2020, the FDA issued a Warning Letter to Anderson Compounding Pharmacy, Inc. following an inspection from March 26 to April 5, 2019. The inspection revealed serious deficiencies in the production of sterile drug products, posing patient risks. A Form FDA 483 was issued on April 5, 2019.

The FDA acknowledged the firm's April 25, 2019, response stating the voluntary cessation of sterile compounding for human and veterinary drugs effective March 25, 2019. The firm also initiated a voluntary recall on April 2, 2019, for all sterile drug products produced from September 25, 2018, to March 25, 2019, due to lack of sterility assurance.

Violations of the FDCA included adulterated drug products prepared, packed, or held under insanitary conditions. Specific observations included: 1. ISO 5 aseptic processing areas with difficult-to-clean and visibly dirty surfaces. 2. Cleanroom and anteroom containing non-microbial contamination and difficult-to-clean surfaces. 3. Unsealed, loose ceiling tiles directly above ISO 5 aseptic processing areas. 4. Failure to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.

The FDA strongly recommends a comprehensive assessment by