FDA 483 - Lowlyn Pharmacies, Inc. - March 08, 2013

The FDA Form 483 details numerous deficiencies at a facility producing sterile injectable drug products for both human and animal use. Key issues include a lack of established procedures to prevent microbiological contamination, specifically for aseptic operations, and no written environmental monitoring plan.

Observations highlighted critical failures in aseptic technique, such as an employee performing sterile operations with gown sleeves rolled up, exposing bare skin. The firm also lacks validation of sterilization processes, has not performed media fills, and does not conduct routine sterility, endotoxin, or potency testing for all sterile drug products prior to release. Examples of untested products approved for shipment include Acetyl-D-Glucosamine 20% 200mg/mL injectable, Diclazuril 500mg/mL injectable, and Cyclosporine 2% Ophthalmic.

Personnel training is deficient, with no documented training for employees involved in sterile drug product preparation. Gowning procedures are inadequate, using non-sterile, non-lint-free materials, and there are no written gowning procedures. Disinfection practices are insufficient, lacking sporicidal agents and using inappropriate cleaning tools.

Facility design is cited for not preventing contamination, with no proper air pressure differentials between classified areas. Container and closure preparation is inadequate, using household methods and lacking evidence of depyrogenation. The firm also lacks a written stability program to justify Beyond Use Dates (BUDs) and has not performed anti-microbial effectiveness testing. Cleaning and sanit