The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Lymol Medical Corporation for failing to comply with the milestone date in the completion of a postmarketing requirement (PMR) for its sterile talc powder.
FDA said the company did not demonstrate a good cause for its failure to complete the study, which was supposed to be a risk assessment study on the lead content of sterile talc powder in line with ICH’s Q3D Elemental Impurities guidance.
“This violation is concerning from a public health perspective because FDA is aware of lead content in sterile talc, and failure to conduct the PMR impedes the evaluation of neurological, reproductive, developmental, immune, cardiovascular, and renal toxicities from lead exposure through use of Sterile Talc Powder,” the 8 January warning letter said.
As far as the timeline of notifying Massachusetts-based Lymol, FDA last August gave the company 30 days to explain its noncompliance, but Lymol did not respond to FDA.
“Failure to promptly correct this violation may result in regulatory actions by FDA without further notice. These actions include, but are not limited to, civil money penalties,” the agency said.
FDA rarely issues warning letters for failing to meet postmarket commitments, although it did previously issue one to Perrigo last year
and one to Merck in 2012
"We’ve made clear that we’re committed to holding companies accountable for completing these important studies on time. The FDA provides guidance and oversight of firms to ensure the studies are completed, and we communicate directly with companies when requirements are missed,” said FDA Commissioner Scott Gottlieb.
Two Other Warning Letters
In addition to the Lymol warning letter, FDA on Tuesday released two other warning letters that were sent to South Korea-based Soleo, which was placed on import alert last November, and China-based Hangzhou Zhongbo Industrial Co., Ltd., which was placed on import alert last September.
For Hangzhou, FDA said the firm, following an inspection last April, had repeat violations and released over the counter (OTC) drug products to the US market without conducting finished product quality testing. The company was also cited for failing to have long-term stability testing data and for failing to test incoming raw materials for their identity, purity, strength and other quality attributes.
Meanwhile, the warning letter to Soleo followed a four-day inspection last August at the company’s site that manufactures OTC shampoo that the company claims can prevent hair loss. The firm was found to lack testing of incoming raw materials, including active pharmaceutical ingredients and components.
“Instead, your firm relied solely on your suppliers’ certificates of analysis (COA) without establishing the reliability of the suppliers’ analyses through appropriate validation,” FDA said.
The agency also noted that Soleo failed to conduct process performance qualification for its OTC drug product.
“You did not demonstrate that your manufacturing process is reproducible and controlled to consistently yield drugs of uniform character and quality. You also did not conduct equipment qualification,” FDA said.
Lymol Medical Corp 1/8/19
Hangzhou Zhongbo Industrial Co., Ltd. 11/27/18