We don’t generally cover warning letters issued for distribution of unapproved new drugs but the one to GOJO Industries Inc., identifies a product that everyone should be familiar with, PURELL® Hand Sanitizer.  The defining sentence in the warning letter is, “Your labeling claims that PURELL® Healthcare Advanced Hand Sanitizers are effective in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, and in preventing the spread of infection, go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings.” Whoops, looks like marketing may have not reviewed the text with the Quality Unit!

Only one device warning letter posted this week and no drug GMP warning letters. Last year was a wasteland for device warning letters, the FDA website identified only eleven for all of FY2019 issued by CDRH. We cover the device warning letter below.

DEVICE | Won Industry Co. LTD

Won Industry Co. LTD (South Korea) received a warning letter on August 29, 2019, based on the outcome of an inspection ending April 11, 2019. This inspection is identified as a follow-up inspection to one ending October 15, 2015 (no, not a typo—it does seem like a long time to wait for a follow-up inspection). The firm was placed on Import Alert 89-08. Many if not all of the deficiencies are repeats from the previous inspection.

Deficiencies include but are not limited to:

  • Failure to investigate the root cause of all deficiencies identified during the 2015 FDA inspection. The firm also has not verified two CAPAs opened to prevent distribution in the US of Class II medical devices with not valid 510(k) to ensure actions taken were effective.
  • The firm’s complaint handling procedure does not require evaluation of the need to report under 21 CFR 803. Nor does it require recording unique identifiers or the complaints phone or contact information. Also, there is no formal group to receive and review complaints. FDA took issue with the firm’s lack of a plan to retrospectively review complaints to see if any should have been reported.
  • The firm does not have a written Device History Record procedure, and after FDA identified instances of DHR’s not including all appropriate information, the firm failed to commit to a retrospective review of DHRs to make sure nothing was missing.  Again, this is an observation from a previous inspection.
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