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Regulatory Focus™ > News Articles > 2019 > 2 > FDA Warns Two Drugmakers for GMP Violations

FDA Warns Two Drugmakers for GMP Violations

Posted 19 February 2019 | By Michael Mezher 

FDA Warns Two Drugmakers for GMP Violations

The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.
 
Vasco Rx
 
FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.
 
At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs produced in its laminar airflow hood over sterility concerns.
 
“During the inspection the investigator noted serious deficiencies in your practices for producing sterile drug products which put patients at risk,” FDA writes, noting that the company’s actions violated the Food, Drug, and Cosmetic Act.
 
According to FDA, the design of the company’s laminar airflow hood is deficient, making certain parts of it difficult to clean. FDA says that smoke studies conducted by the company showed turbulent airflow near the work surface for aseptic production.
 
FDA also observed several shortcomings in the firm’s aseptic processing practices, including the use of non-sterile wipes for disinfection, a technician placing their head in the laminar flow hood during aseptic production as well as a technician touching the inner surface of a container closure during aseptic production.
 
Samson Pharmaceuticals
 
In December, FDA sent a warning letter to Samson Pharmaceuticals over violations stemming from an inspection in January and February 2018 detailing issues with the company’s aseptic processing and product testing practices.
 
According to FDA, the “floors in the aseptic facility are damaged and walls are cracked, rendering them difficult to clean and disinfect. We also observed peeling paint on cleanroom wall surfaces, which can be a source of foreign matter contamination.”
 
FDA says the company did not set alert and action levels for personnel monitoring samples, which were found to be over appropriate microbial count levels in the company’s ISO 5 area.
 
“Exceedingly high microbial counts were obtained on gloves and other gowning locations of operators participating in the manufacturing operations for Pure Eyes [sterile eye drops],” FDA writes. FDA notes that the company also failed to perform a long-term room temperature stability study for the product.
 
FDA also cites the company for failing to conduct media fill simulations at appropriate intervals, pointing out that the company only performed one media fill simulation for its sterile eye drops between 2015 and 2017.
 
“There is no assurance that your firm can consistently and reliably produce sterile drug products because of your substantial lack of aseptic processing operation validation,” FDA writes.
 
Additionally, FDA says the company improperly relied on its suppliers’ certificates of analysis (COA) when it should have conducted component identity tests itself.
 
“For example, [Samson] did not test each lot of glycerin for diethylene glycol (DEG) and ethylene glycol (EG), two hazardous impurities that would be detected with the [United States Pharmacopoeia] USP identity test method,” FDA writes.
 
Warning Letters: Vasco Rx, Samson Pharmaceuticals

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