- Delivery Method:
- VIA UPS
- HealthMEDS Inc.
10926 NE Shaver St.
Portland, OR 97220
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
Warning Letter 320-21-61
September 29, 2021
4207 SE Woodstock Blvd 562
Portland, OR 97206
Dear HealthMEDS Inc.:
Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed include ProClean-Pure Atomizer Mist 5 mL. On February 1, 2021, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered, as did numerous telephone calls from the Agency regarding this matter, so the Agency sent a follow-up written request for such records and other information by certified return-receipt mail on May 6, 2021. You failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.
It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).
Since declaration of the COVID-19 public health emergency,1 a number of hand sanitizer products have been recalled due to quality issues ranging from substitution with other drug substances to subpotency.2 The Agency has reached out to registered OTC drug firms with hand sanitizers included in their product listing to assess the overall quality of the drugs registered as manufactured by these firms. Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.
Respond to this letter within 48 hours to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information. If you are no longer manufacturing drugs, delist all the drugs previously listed with FDA, using the last lot expiration date as the marketing end date of the product, and deregister your facility accordingly.
The Agency may conduct an inspection to verify information provided and/or to evaluate the compliance of your manufacturing operations.
Continued non-response regarding questions of the quality assurance of the drugs manufactured at your facility may lead to inclusion on the Agency’s list of hand sanitizers consumers should not use, at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.
You may provide additional information for our consideration as we continue to assess your activities and practices.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.
Identify your response with FEI 3016884869 and ATTN: Rokhsana Jazi.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA
1 The HHS Declaration of a Public Health Emergency is available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
2 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance.