FDA Issued Two New Warnings to Drugmakers

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The US Food and Drug Administration (FDA) recently warned Massachusetts-based device maker Conformis Inc. and Australian over-the-counter (OTC) drugmaker Wild Child WA Pty Ltd. for good manufacturing practice (GMP) issues uncovered during inspections earlier this year.

Conformis Inc.

FDA’s warning letter to Conformis comes after a seven-day inspection in September and November of this year for failing to establish and maintain an adequate corrective and preventative action (CAPA) plan to address sterility issues for one of their products.

In a filing with the Securities and Exchange Commission (SEC), Conformis explains that the warning letter “concerns the number of sterilization cycle failures relating to Vaporized Hydrogen Peroxide (VHP) sterilizers that the company uses as a limited, alternative sterilization method for a small quantity of products. It does not question product sterility.”

The company notes that it plans to respond to FDA “in a timely manner” and says it is planning to decommission and replace the VHP sterilizers.

Wild Child WA Pty Ltd.

In its warning letter to Wild Child, FDA cites the company for three GMP issues stemming from a five-day inspection of the company’s Malaga, Australia facility.

All three of the citations involve issues with the company’s procedures for testing its products and ingredients.

According to FDA, the company released batches of OTC drugs intended for the US market “without adequately testing the identity and strength of the active ingredient” by relying on an “inferior” method of analytical testing compared to the one called for in the United States Pharmacopeia (USP) monograph for that ingredient.

FDA also says the company does not have adequate monitoring process controls to ensure stable operations, consistent drug quality and did not have documentation showing that certain manufacturing processes had been validated.

Additionally, FDA cites the company for failing to test the identity of all incoming components used to make its OTC drugs intended for US distribution.

SOURCE: raps.org
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