FDA 483 - Mixlab TX LLC - June 14, 2017

The FDA inspection revealed significant deficiencies at a facility producing sterile injectable drug products for animals. Procedures to prevent microbiological contamination were not established. Specifically, dynamic smoke studies of ISO5 areas were not conducted, and non-sterile wipes and sporicidal disinfectants were used for cleaning ISO5 surfaces. Glass vials, rubber stoppers, and glassware for sterile injectable products were sterilized but not depyrogenated.

Gowning practices were inadequate; sterile technicians wore non-sterile booties, hairnets, and masks, leaving the forehead, eye area, and neck exposed in the ISO7 cleanroom and ISO5 LAFH, posing contamination risks.

Furthermore, the firm's animal drug products, including Altrenogest 2.2mg/ml oral suspension, Nitrofurazone 0.2% topical, and Diclofenac cream 1%, were deemed unsafe and adulterated as they lacked approved new animal drug applications, conditional approvals, or index listings under the FD&C Act.

The firm also failed to investigate and document potency failures for multiple compounded preparations, including Buserelin Acetate (122.7%), Xylazine HCL (119.1%), Folic Acid (88.8%), Omeprazole/Misoprostol (74.7%), Ketoprofen/Glucosamine (Glucosamine 80.0%), Testosterone Cypionate/Anastrozole (Anastrozole 10.3%),