HealthMEDS Inc.

Warning LetterOpen

HealthMEDS Inc. 10926 NE Shaver St. Portland , OR 97220 United StatesFEI 3016884869Issued Sep 29, 2021Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016884869.

Violations0

Issue DateSep 29, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: HealthMEDS Inc.
Location: HealthMEDS Inc. 10926 NE Shaver St. Portland , OR 97220 United States
FEI Number: 3016884869
Country: United States
Issue Date: September 29, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

HealthMEDS Inc., a manufacturer of over-the-counter drug products including ProClean-Pure Atomizer Mist, failed to respond to FDA records requests issued on February 1, 2021, and a follow-up certified letter sent May 6, 2021, in violation of section 704(a) of the Federal Food, Drug, and Cosmetic Act. The company did not provide requested records or information despite multiple electronic and telephone communications from the Agency, constituting a prohibited act under section 301(e) of the FD&C Act. The FDA's request was part of a broader quality assessment initiative for hand sanitizer products, following numerous recalls due to quality defects ranging from drug substance substitution to subpotency during the COVID-19 public health emergency.

HealthMEDS Inc. FDA Warning Letter, September 29, 2021