FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.
The FDA issued warning letters to UCSF Radiopharmaceutical Facility and Par Health after inspectors found fault with their environmental monitoring practices.
FDA inspectors visited the UCSF facility, which makes radiopharmaceutical tracers, last July. In a warning letter published April 13, the agency said the facility’s quality unit failed to investigate when multiple environmental monitoring results fell outside of the action limit. The facility also performed inadequate investigations of multiple failing sterility test results, according to the letter.
The FDA told UCSF that the short expiry periods of radiopharmaceuticals make environmental monitoring particularly important. Many of the drugs made at the facility have half-lives measured in minutes and, as such, are released and administered before the results of batch-specific sterility testing.
A robust ongoing monitoring program is essential for detecting and acting on potential contamination hazards in a timely manner, the FDA said. The agency warned that losing environmental control in an aseptic manufacturing facility can ultimately pose a serious hazard to patients.
“Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP [Current Good Manufacturing Practice] requirements,” the FDA said.
The agency asked UCSF to provide an independent assessment of its environmental monitoring program. This assessment should cover topics including establishing appropriate limits, sampling locations and frequencies and investigating deviations, according to the FDA. Other agency demands include an independent review of all invalidated sterility test results for U.S. products for the last three years.
Days later, the FDA published a warning letter to Par Health, a company created last year through the merger of Mallinckrodt and Endo. The Michigan facility, ENDO USA, is a contract manufacturer of sterile injectable drug products made primarily through aseptic processing, according to the agency.
Inspectors found Par failed to ensure adequate environmental monitoring of classified areas used for aseptic production of sterile injectable drug products. Further, Par failed to show that its equipment for collecting particulate monitoring samples provides meaningful and representative samples, the FDA said.
The agency requested a comprehensive, independent risk assessment of all contamination hazards related to aseptic processes, equipment and facilities. The assessment should cover human interactions and air quality in the cleanroom.
A recent warning letter issued to New Life Pharma also covered environmental monitoring. The company, which refused inspectors access to parts of its facility, failed to establish a routine environmental monitoring program at a site making GLP-1 drugs, according to the FDA.
