Hyderabad: The US Food and Drug Administration has issued a warning letter to global pharma major Mylan Laboratories Ltd for significant deviations from Current Good Manufacturing Practices (CGMP) for making active pharmaceutical ingredients (APIs) at its plant in Telangana.
The drug regulator expressed concerns about Mylan’s lack of cleaning records and inadequate quality control for certain manufacturing and storage equipment at its Unit 7 at Pashamylaram, Patancheru in Sangareddy district.
The FDA alleged in its letter dated September 1 that Mylan did not do a sufficient job testing all incoming raw materials to ensure they are suitable for the manufacturing process and didn’t have adequate procedures for detecting impurities. It observed that this coupled with using non-dedicated equipment, created the risk of contaminating the ingredients that go into Mylan’s medicines.
The federal agency stated that its investigators during the inspections of the facility between February 24 and 28 this year found lapses in the plant as there were no adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.
“In addition to your lack of cleaning records, your cleaning validation and verification programme for non-dedicated manufacturing and storage equipment are inadequate,” the FDA said.
This is the second warning letter by FDA to Mylan for similar issues in less than a year. The drug-maker was issued a warning letter in November last year for another unit in Andhra Pradesh.
The warning was issued for Unit 8 for 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.
“We observed similar deficiencies related to inadequate storage and handling of recovered solvents utilised at your Unit 7 API manufacturing operations. 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,” reads the FDA letter.
“Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” it added.
Mylan, however, said it does not anticipate any interruption in manufacturing and distribution at the site.
“The US Food and Drug Administration (FDA) issued a Warning Letter to Mylan’s API manufacturer, Mylan Laboratories Ltd – Unit 7, in which no interruption in manufacturing and distribution is anticipated at the site, no significant commercial impact is expected and no significant launches are planned for Unit 7 in 2020,” Mylan said in a statement.
It said several months prior to the inspection, it put additional controls, corrective actions and improvements in place at the facility to mitigate any perceived risk of product contamination with patient safety as its primary focus.
“Importantly, extensive testing of APIs manufactured and distributed by the site was performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified,” said Mylan which is incorporated in the Netherlands but has corporate headquarters in the US.
Mylan said it will submit its response to the letter within the required time period of 15 working days.
“Mylan is committed to maintaining the highest quality manufacturing standards at all of its facilities around the world. We have an industry-leading track record in global quality management, and we take very seriously our continued and comprehensive oversight of Mylan’s entire manufacturing network,” it added.
