Infusion Options Earns Warning Letter Over Sterility Concerns

July 18, 2016

The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations.

An April 2014 inspection at the company’s Brooklyn, N.Y. facility found that products intended to be sterile were prepared, packed or held under unsanitary conditions.

For example, the firm failed to perform environmental monitoring for viable air in the ISO 5 zone and “failed to demonstrate through appropriate studies” that the hoods adequately protect the ISO 4 area where sterile products are processed, the agency said.

The firm also failed to meet 503B conditions for an outsourcing firm, because it didn’t provide the agency with a six-month report of all drugs compounded.

The agency took the firm to task for failing to provide adequate product directions, such as a dosage form, manufacturer information, route of administration and required statements.

GMP violations included not instituting a system to validate aseptic processes and prevent contamination, lacking a system to monitor aseptic conditions and failing to ensure batch sterility.

The agency highlighted numerous lapses in corrective and preventive actions, noting that the company’s proposed frequency for environmental monitoring was inadequate.

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