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The agency cited the company for sterile manufacturing violations.
FDA sent a warning letter on June 13, 2016 to S.R. Burzynski Manufacturing Facility for violations of current good manufacturing practice (CGMP) at the company’s Stafford, TX, facility. The company was cited for improper sterile manufacturing of finished drug products during a March 2015 inspection.
According to FDA, the company failed to established written procedures for the prevention of microbiological contamination of sterile products and failed to use appropriate equipment. “Your poor facility and equipment design inadequately protects the sterile (b)(4) product during manual manipulations, poses a substantial hazard to product sterility, and presents an unreasonable risk to patient safety. For example, you manually process materials in an ISO 5 (class 100) clean zone on a (b)(4) open to the surrounding ISO 7 (class 10,000) clean room environment. This arrangement permits the ingress of low quality air into the aseptic processing environment,” FDA stated in the letter.
Cleaning, environmental monitoring, and control of aseptic conditions were also inadequate. FDA investigators observed personnel inappropriately cleaning and disinfecting manufacturing rooms and equipment. The company could not provide FDA with the proper environmental monitoring documentation or assurance that the HEPA filters in the ISO 5 clean zone functioned properly.
Personnel were also seen not wearing the appropriate clothing to protect drug contamination. “The garbing (consisting of face masks, hair nets, gloves, and suits without hoods) used at your facility is not adequate to protect the drug product from microbiological contamination during sterile processing. During your demonstration of cleaning and disinfection practices for your aseptic processing room, our investigators observed an operator who wore eye makeup with no eye protection. The operators wore clothing that allowed for exposed skin on their faces and necks. Furthermore, personnel reused these suits on multiple aseptic processing production days, with no cleaning or sterilization between uses,” FDA stated in the letter.
FDA states that the company’s response to the violations does not adequately address contamination hazards, which “demonstrate significant risks to patient safety, especially because immunocompromised individuals may receive your firm’s drugs.” The agency suggests the company hire a qualified consultant to assist the company in meeting CGMP requirements.