The FDA issued a warning to Lymol Medical for failing to submit a final postmarketing requirement (PMR) report on its sterile talc product without providing a good explanation for the delay.
The agency previously reached out on Feb. 5, 2018, to notify the Woburn, Massachusetts firm about a PMR it was required to complete under its NDA for the product. The company needed to perform a risk assessment on the lead content of its sterile talc powder and to note any needed controls on elemental impurities.
The company failed to submit the PMR on time and drew a Failure to Respond Letter in September after ignoring reminders from the agency. “Failure to comply with PMR milestone dates without demonstrating good cause for noncompliance” is a violation that renders the product misbranded, the agency said.