Compounders Slammed With Warning Letters Over Tainted Drug Products
Three compounders have been accused of adulteration and misbranding in the FDA’s latest round of warning letters.
An inspection of Pinnacle Compounding Pharmacy’s facility in Las Vegas, Nev., concluded that it manufactures products under unsanitary conditions, rendering those products adulterated.
For instance, investigators spotted an expired disinfectant in the facility and concluded that employees did not follow instructions to ensure an adequate contact time for sporicidal agents. The agency noted that the facility did not conduct the appropriate tests to ensure adequate protection of the ISO 5 area, where sterile products are processed.
Additionally, investigators found production occurred in the facility’s cleanroom while the positive pressure differential to the anteroom was below specification.
The inspection turned up seven other issues, such as failing to establish and follow appropriate written sterility procedures; the lack of an adequate system for monitoring environmental conditions; the absence of an appropriate air supply; the need for a sufficient system for cleaning and disinfecting rooms and equipment; and appropriate lab determinations to ensure satisfactory conformance to final specifications for drug products.
According to the letter, the facility was also deficient in ensuring that manufacturing personnel wore clothing appropriate to protect products from contamination and drug products contained an expiration date.
All the allegations stem from an inspection conducted in July 2015.
The facility is no longer registered as an outsourcing facility and told the agency it registered as an outsourcing facility in error. Despite this, the agency still recommends management undertake a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, materials and systems.
Compounding Pharmacy of America
Similarly, investigators cited the Compounding Pharmacy of America for issues at its Nashville, Tenn., facility.
According to the warning letter, investigators witnessed technicians prepare sterile drugs in casual clothes, without wearing proper gowning in an unclassified room with no HEPA filtration. The letter additionally notes the facility’s failure to include a sporicidal agent as part of its disinfection program for aseptic processing areas.
Furthermore, the facility did not demonstrate adequate protection of the ISO 5 area.
The agency also cited the facility for failing to establish and follow procedures for aseptic processing that includes temperature and humidity controls; neglecting to establish and follow an adequate written testing program to assess the stability characteristics of drug products; and failing to establish an adequate air supply filtered through high-efficiency particulate air filters.
Investigators during the May 2015 inspection additionally found the facility produced unapproved drug products because it did not have FDA-approved applications on file for the products.
The facility voluntarily recalled all sterile drug products distributed between November 2014 to May 2015. The agency found most of its corrective actions adequate, but asked for interim actions before corrective measures are fully implemented.
The agency also recommended a comprehensive assessment of the facility’s operations, including facility design, procedures, personnel, processes, materials, and systems.
People’s Custom Rx and Clinical Care
Inspections conducted in July 2015 at a facility in Memphis, Tenn., run by People’s Custom Rx and Clinical Care identified adulterated, misbranded and unapproved products, related to similar unsanitary conditions.
For example, the facility failed to use a sporicidal agent and non-sterile disinfectants for daily cleaning of the ISO 5 hoods and clean room. Additionally, it established no assurance of the sterility for multi-use solutions used to produce injectable products.
Investigators also found the facility did not conduct smoke studies for the ISO 5 hoods under dynamic conditions.
According to the letter, drugs were unapproved and misbranded due to a lack of FDA-approved applications on file and failure to provide adequate directions for use.
The agency generally found the company’s corrective actions adequate, but requested a description of procedures and cleaning agents the facility will use to fully evaluate the measures.
The compounders did not respond to requests for comments.
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