LeeSar, Inc. – FDA Warning Letter, Jul 12, 2017

The FDA issued a Warning Letter to Leesar, Inc., an outsourcing facility, following a July 2017 inspection that revealed significant violations. The facility failed to meet conditions under section 503B of the FDCA, jeopardizing exemptions from drug approval and labeling requirements. Key deficiencies included the failure to submit complete product reports in June and December 2017, as mandated by section 503B(b)(2) of the FDCA. Furthermore, the facility did not comply with section 503B(b)(5) regarding adverse event reporting, with inadequate procedures that incorrectly advised employees to use the wrong reporting form (FDA-3500B instead of FDA-3500A). Additionally, Leesar, Inc.'s compounded drug products were deemed misbranded under section 502(f)(1) of the FDCA due to a lack of adequate directions for use, as they are intended for conditions requiring professional diagnosis. The facility's submitted Standard Operating Procedure for adverse event reporting was found to be inadequate, lacking crucial details on submission processes, data elements, definitions of serious adverse events, timelines, follow-up procedures, and record retention, thus failing to comply with 503B(b)(5) and 21 CFR 211.198. The FDA requires prompt corrective actions, including a written response within fifteen working days detailing steps taken to address these violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction, and continued loss of 503B exemptions.