FDA cites drug, hand sanitizer and face mask firms with CGMP violations
The US Food and Drug Administration (FDA) released three warning letters sent over the past few months that were directed at manufacturers for violating current good manufacturing practices (CGMP).On 14 February, FDA published three letters it sent to companies that failed to comply with CGMP requirements. The first letter, dated 13 February, is to Istanbul-based drugmaker Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil. The agency noted that the manufacturer failed to test samples of components it received from suppliers for identity and conformity to determine purity, strength and quality of the raw materials used to make their drugs.
“You failed to adequately test your incoming components for identity before using the components to manufacture your over-the-counter (OTC) drug products,” FDA said. “You also failed to adequately qualify your suppliers, as you have not validated the test results of your suppliers’ analyses and instead relied on your suppliers’ responses to your vendor questionnaire.”
FDA said the Turkish manufacturer instead relied on certificates of analyses (COA) from unqualified suppliers to determine specifications such as purity, strength and quality of the chemicals used to make their OTC drugs. The firm was also cited for failing to develop adequate written procedures to assure the specifications are met and represented in the final product.
Based on Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil’s CGMP violations, FDA said the company should hire a CGMP qualified consultant who can help it meet the agency’s requirements and respond to the warning letter.
“The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA,” the agency added.
FDA also sent a warning letter to Moorpark, CA-based hand sanitizer maker Clean Cosmetics late last month for not conforming to CGMP requirements and selling hand sanitizers laced with methanol instead of ethanol, among other violations. The firm was also cited for failing to adequately test the incoming raw materials from suppliers before using them in their OTC drug products and for relying on COAs without performing identification testing.
“While you indicated that the hand sanitizer drug product manufactured with this lot of ethanol was not distributed to the market, your firm manufactured and released … lots of hand sanitizer drug product using ethanol, which contained unacceptable levels of methanol,” FDA said. “The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide.”
Since FDA first raised issues with Clean Cosmetics’ procedures, the company told the agency it was working with a consultant and is in the process of developing and implementing a fully compliant quality system. FDA noted in the letter that it has not provided further details about the company’s plans, such as a timeline for taking actions or an action plan.
“We acknowledge your commitment to cease production of drugs at this facility,” said FDA. “In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future.
If you plan to resume manufacturing drugs, ensure that adequate corrective actions are in place and notify this office to schedule a meeting before resuming your operations.”
On 16 November, FDA sent Wintech Medipro, based in Katy, TX, a warning letter for marketing surgical masks without marketing approval, clearance or authorization from the agency. The manufacturer was further cited for not notifying regulators that they intended to market regulated products in the US. It was also cited for not following CGMP requirements.
“Your firm should take prompt action to address any violations identified in this letter,” said FDA. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
