FDA Cites California Devicemaker for Procedural Failures

January 15, 2020

The FDA wrote up Anaheim, California device manufacturer Anacom MedTek in a Form 483 over multiple procedural lapses at its facility.

Agency investigators found that there were no procedures in place for performing functional testing on finished pillow speaker products, which double as TV remotes and nurse communication devices for hospitalized patients.

The company’s supplier control procedure was also inadequate in that it wasn’t detailed enough to ensure the company reviewed and approved its suppliers based on their ability to meet quality requirements.

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