FDA Sends Mylan Warning Letter

September 2, 2020

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA sent a warning letter to Mylan Laboratories Limited–Unit 7, dated Aug. 20, 2020, after an inspection of the company’s Pashamylaram, Patancheru (M), Sangareddy District, India facility found deviations in current good manufacturing practices (CGMPs) for API. The inspection was conducted from Feb. 24–28, 2020.

According to the letter, the facility did not have cleaning procedures adequate enough to prevent contamination or carry-over of material. Specifically, the company did not have adequate cleaning records for storage tanks. “During the inspection our investigators queried your firm on the quality of recovered solvents held in these storage tanks. Your firm management stated that complete impurity profiles of recovered solvents were not performed during the initial evaluation of your solvent recovery contract manufacturing organizations (CMO). Coupled with inadequate cleaning records, there are limited assurances that your non-dedicated equipment would not contribute to cross-contamination or carry-over of residual impurities,” the letter stated. The agency also stated the company used a CMO that was on Import Alert 66-40 and had received an FDA warning letter.

FDA also stated that the company had an inadequate cleaning validation and verification program for non-dedicated manufacturing and storage equipment. “An inadequate scope of impurity analysis, in combination of non-dedicated equipment, lack of cleaning records, and introduction of elevated unknown impurities, increase the risk potential for API and API intermediate cross-contamination,” the agency stated.

The agency requested the company provide a third-party retrospective assessment of its cleaning effectiveness to determine cross-contamination hazards, improvements to its cleaning validation program, and summary of steps to be taken to update its change management system.

The company was also cited for failing to control and monitor procedures to recover solvents before reuse, including not adequately testing incoming raw materials. FDA requested the company provide a detailed plan for monitoring unknown impurities from fresh solvents, a plan for monitoring process control, procedures for impurity profile analysis, and an updated procedure for evaluating unknown peaks in chromatograms.

FDA stated in the letter that similar CGMP violations were found at another facility in the company’s network. “On November 5, 2019, Mylan Laboratories Limited – Unit 8, FEI No. 3002785310, was issued Warning Letter 320-20-06 for, among other things, failure to have adequate written procedures for receipt, identification, testing, and handling of raw materials and a failure to clean equipment and utensils to prevent contamination or carry-over of material. The poor controls of recovered solvents at this facility led to contamination of drugs with (b)(4) impurities,” the letter stated. “These repeated failures at multiple sites manufacturing API demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites,” FDA stated.

Source: FDA