Mikala Hukka

What are the compliance standards followed at Adaptive Health

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Mikala Hukka

In this video, Mikala outlines the compliance standards followed at Adaptive Health. She delves into the various regulatory requirements they adhere to and how maintaining these standards is critical for their operations. Mikala explains how Unifize plays a vital role in ensuring compliance, managing documentation, and streamlining processes to meet these rigorous standards effectively.

SpeakerMikala Hukka
IndustryNutritional Supplements
Runtime1:02

Transcript

6 passages · 1:02
  1. 0:00

    So 111 is specific to dietary supplements.

  2. 0:02

    So the food safety aspect, making sure everything is, that's getting to the end consumer is safe, of course, meaning we follow FTC, too. So a lot of the marketing claims that we make, we have to make sure they're realistic and not misleading to any consumers.

  3. 0:16

    But I would say the the main takeaway is just the food safety aspect of it.

  4. 0:20

    21 CFR part 111, 117 and then part 11 with inherently built into all of our quality processes.

  5. 0:28

    We do a lot of our own raw material sourcing. So making sure that when our manufacturers are testing the raw material that it is meeting ID and ASCI requirements, we review those as well. We don't rely solely on our contract manufacturers to qualify materials and then we obviously qualify are our manufacturers.

  6. 0:45

    So in addition to Biovation we have ten plus other co-mans that we use. So going on site, auditing their individual processes to make sure everything they're doing is up to code that's been in compliance with Part 111.

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