The FDA issued a warning letter to a Texas drugmaker, citing four GMP violations related to sterility.
A March 2015 inspection found Stafford-Texas based S.R. Burzynski Manufacturing facility neglected to establish procedures to prevent microbiological contamination and failed to use appropriate equipment for manufacturing, processing and holding sterile products.
For example, the facility had not established procedures to ensure the facility’s manual aseptic process is capable of yielding sterile units. Additionally, the facility’s arrangement permitted low quality air to enter the facility’s aseptic processing environment.