FDA 483 - Morton Drug Company dba Morton LTC - August 31, 2018

On August 27-31, 2018, the FDA inspected Morton Drug Company dba Morton LTC, a producer of sterile and non-sterile products located at 201 E Bell St, Neenah, WI. The inspection, led by Investigators Sandra A Hughes and Tenzin Jangchup, resulted in three observations.

Observation 1 noted inadequate cleaning of work surfaces to prevent cross-contamination for beta-lactam drugs. Specifically, beta-lactam antibiotics were aseptically processed in the ISO 5 area within the past three months, but the cleaning procedure lacked appropriate cleaning agents to mitigate cross-contamination risks.

Observation 2 identified that materials and supplies were not adequately disinfected before entering aseptic processing areas. On August 27, 2018, an operator was observed wiping supplies in the ISO 8 area with a solution and transferring them directly into the ISO 5 aseptic processing area without further disinfection. These supplies were used for aseptic processing of daptomycin 425 mg in 100 mL of 0.9% NaCl.

Observation 3 stated that media fills did not closely simulate aseptic production operations or incorporate worst-case activities and conditions to challenge aseptic operations. The firm's media fill practice involved injecting a substance other than a microbiological growth medium in place of the product.