Daewoo Pharmaceutical Ind Co.,Ltd.

The FDA found manufacturing concerns at plants run by Sun Pharma, Daewoo Pharmaceutical and Glenmark. The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging from mold to skirted testing procedures. A Sun Pharma plant in Gujarat, India was subject to a 19-page tally of eight observations (PDF) flagged at an agency inspection in early June, with some repeat offenses from a previous FDA warning letter in 2022. For example, the FDA had previously observed instances of “poor aseptic behavior and inadequate environmental monitoring,” which was again seen during the more recent visit.The agency specifically reported that the generic drugmaker did not establish and follow procedures meant to prevent microbiological contamination. Some of these concerns centered on the plant’s gloving and aseptic gowning practices, such as one operator’s gown making contact with a trash can and another removing vials with gloved hands as opposed to forceps. The other observations concerned improper batch testing in the quality unit, potentially incomplete control records and shoddy equipment. For example, the FDA spotted a liquid dripping from the ceiling cracks in a stability chamber covered by seemingly broken sealant. The liquid was falling through what appeared to be “potential growth of bacterial, fungal and mold” described as “dark black to brown to reddish and off-white.” The stability chamber in question houses sterile drug products for U.S. and other markets, the FDA noted.Sun’s Gujarat plant previously landed on an FDA import alert in 2022.Meanwhile, a Daewoo Pharm site in Busan, Korea, received a warning letter on July 2 after an FDA inspection earlier this year. The company had replied to a previous Form 483 in February, but its responses were largely viewed as inadequate, leaving the plant’s products currently considered “adulterated” by the FDA due to “significant” violations of manufacturing regulations.The agency listed five main concerns in the contamination, quality control and cleanliness realms with evidence ranging from improper sterilization of equipment to inadequate environmental monitoring and visual inspection. Some of the more damning examples cited by the FDA was mold in “multiple areas” of the facility that Daewoo failed to properly investigate, plus late testing on certain samples despite a “substantial number of complaints for burning or redness,” which suggested potential contamination.Daewoo’s site has also failed to maintain a robust sampling and testing plan for a component. Contamination of that component at other manufacturers has in the past resulted in “various lethal poisoning incidents in humans worldwide,” the FDA notes. The Korean drugmaker specializes in ophthalmology and pledges to “take care of the eye health of people across the world.” The company’s Busan plant makes tablets, capsules and eye drops and sells its products in Targets and Walgreens across the U.S. However, the FDA notes in its warning letter that Daewoo deregistered the facility, and the agency is seeking clarification on if the company intends to continue making U.S. drugs in the future, suggesting a consultant to help meet manufacturing standards.Finally, Glenmark acknowledged receipt of an FDA warning letter from an inspection of its site in Madhya Pradesh, India. The company “does not believe” that the letter will impact supplies or revenue from the plant and is “committed to addressing the concerns” and working with the FDA to resolve the issues, according to a securities filing. None of the observations were related to data integrity, the company clarified.