FDA WARNING_LETTER - Malanda - July 25, 2019

From June 17 to July 25, 2019, the FDA inspected Malanda, Inc. dba Mandell’s Clinical Pharmacy, identifying serious deficiencies in sterile drug product production, leading to a Warning Letter on June 9, 2020. The firm received a Form FDA 483 on July 25, 2019, and responded on August 12, 2019.

The FDA found drug products adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Violations included processing sterile drug products in an ISO 5 laminar flow hood within an uncontrolled environment, with water dripping nearby. The firm failed to use a sporicidal agent correctly for ISO 5 and ISO 7 areas, used non-sterile equipment for sterile drug mixing, and inadequately handled hazardous drugs, risking cross-contamination. These acts violate FDCA sections 301(a) and 301(k).

While some proposed corrective actions were adequate, the FDA requires more information. The firm must update on its commitment to cease using the "Laminar Flow (b)(4)" until compliant, providing documentation if aseptic production has resumed. They also need to provide updated cleaning procedures for sporicidal use in classified areas, procedures to prevent pyrogenic properties from non-sterile equipment, and procedures for adding deactivation/decontamination agents