Infusion Options, Inc.
FDA issued a warning letter to Infusion Options, Inc. (Brooklyn, NY), an outsourcing facility registered under section 503B, following a 2019 inspection that found sterile drug products produced under insanitary conditions, multiple CGMP violations, missing required labeling elements, and failure to submit mandatory biannual drug product reports to FDA. The compounded drug products were deemed adulterated under section 501(a)(2)(A) and (B) and misbranded under section 502(f)(1) of the FDCA. The facility had already voluntarily recalled all sterile products, permanently discontinued 503B compounding, and de-registered as an outsourcing facility prior to the letter. FDA required written acknowledgment within 15 working days and warned that failure to address violations could result in seizure or injunction.
Flagged claims (4)
drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health
Some of your facility's drug products did not include the following information on the container: information to facilitate adverse event reporting, http://www.fda.gov/medwatch and 1-800-FDA-1088.
Your facility failed to submit reports to FDA in June 2014, December 2016, December 2017, June 2018, December 2018, and June 2019, identifying the drug products that you compounded during the previous 6-month period.
Some of your facility's drug products did not include the following statements on the label: "This is a compounded drug," "not for resale," the date of compounding, and the lot or batch number.
Required actions (4)
Within fifteen (15) working days of receipt of this letter, please acknowledge receipt of this letter and confirm in writing your continuing intention to not resume production, holding, or distribution of drug products.
If you intend to resume such activities in the future, please include a current and updated explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
you should notify this office fifteen (15) working days prior to resuming production, holding, or distribution of drug products in the future.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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