FDA warns diagnostic maker for failing to seek approval for changes, OTC firm for lax investigations

The US Food and Drug Administration (FDA) recently sent warning letters to a subsidiary of device manufacturer Abbott and to an over-the-counter (OTC) drugmaker following inspections in 2022.

FDA inspectors audited Abbott Point of Care in May 2022 at its site in Ottawa, Canada. The company makes a device used to measure troponin in the blood that are intended to diagnose and treat myocardial infarction.

FDA said the device is adulterated because the company did not seek approval before making major changes to the product since it was first introduced in 2003. These changes render the device substantially different from the original product, the agency asserted.

One modification involved making “multiple significant design changes” to the cartridge, including a process change the replaces monoclonal antibodies in the product with a new cell culture.

Another change made to the cartridge and impacts the device’s ability to accurately measure troponin concentrations. This change “significantly modified existing risks and could significantly affect the safety or effectiveness of the devices and requires submission of a new premarket notification (510(k).”

“Inaccurate troponin results, a time-critical analyte, due to these changes, may lead to false negative or false positive results which may lead to significant consequences to patients including death. The above-referenced changes, individually and collectively, significantly modified existing risks to the subject device and could significantly impact safety and effectiveness of the subject device,” FDA wrote.

FDA said that since the company did not notify the agency of these significant changes before introducing these modifications, and did not submit a new 510(k) for these modified devices, they are “unapproved because it is no longer considered to be substantially equivalent to the predicate devices described in your existing 510(k)s.”

Zermat faulted for inadequate failure investigations for OTC drugs

In a separate action, FDA issued a warning letter on 6 April to Zermat Internacional in Tlalnepantla, Mexico for “significant violations” of good manufacturing practices (GMPs) related to their production of an OTC product.

Investigators said the firm failed to thoroughly investigate out of specification results. The company released and distributed batches of viscous products without investigating the reason.

The firm also failed to establish a written testing program to assess the stability of drug products which are used to determine storage conditions and expiration dates. FDA said that “your stability procedure requires an organoleptic assessment (odor, color, appearance) of your OTC drug products only at four-weeks. Although, your procedure references long-term stability at ambient temperature, your firm did not provide evidence of long-term stability.”

The agency reminded the firm that that “you are responsible for assuring your manufacturing processes will consistently result in drug products meeting predefined quality attributes.”

Abbott warning letter

Zermat warning letter

FDA warns diagnostic maker for failing to seek approval for changes, OTC firm for lax investigations

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