Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control.
Scot Silber, president and CEO of Green Valley, said at the time the company was working with the agency and the Nevada pharmacy board to rectify concerns raised by investigators during an early March inspection of its Henderson, Nev., compounding facility.
But a warning letter followed six months later, citing similar concerns that led to the mass recall.
Investigators observed significant violations of current good manufacturing practices at the site, including the storing of sterilized vials uncovered and unprotected from microbial contamination, the letter published Dec. 17 states. Officials also found evidence that Green Valley does not receive valid prescriptions for individually identified products for various drugs that it produces.
Therefore, many of the drugs produced at the Henderson facility, including two marketed doses of methylprednisolone acetate, are deemed new drugs under the 1938 FD&C Act and require new drug applications, the FDA said. The drugs also require detailed labeling, which they lack.
The agency also listed a number of procedures and controls the Green Valley facility lacks and that are required for compliance, including those that would prevent contamination of sterile drugs; define areas or other control systems to prevent contamination or mix-ups; assess product stability; clean and disinfect rooms and equipment; and monitor the manufacturing environment.
Green Valley also does not have, for each batch of sterile drugs, appropriate laboratory determination of satisfactory conformance to final product specifications, the letter adds.
The FDA asks Green Valley to conduct a comprehensive assessment of its manufacturing operations, with a focus on the acceptability of its aseptic processing operations, and suggests a third-party compliance auditor would be useful in that regard.
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