FDA’s warning letter to Alchymars ICM SM Private Limited (not yet publicly posted at time of publication), dated May 21, 2026, documents equipment in “various levels of disrepair”: cracked, taped, and deteriorating gaskets; rust-like residues on product-contact surfaces; and wet paint applied during active API production at the firm’s Tamil Nadu facility.
Inspectors arrived unannounced in late 2025. Cleaning and preventive maintenance records logged the same deteriorated equipment as “OK.” Alchymars blamed the inaccurate recordkeeping on “insufficient inspection rigor” and attributed the physical failures to an absence of a lifecycle management program.
FDA found the response inadequate. There’s no residue testing on contaminated equipment, and no explanation for how the quality system had overlooked obvious maintenance failures, even as the company began repairing equipment and overhauling its cleaning, maintenance, and gasket procedures.
I read the 2018 warning letter when the closeout came through in January 2023. It cited a manhole gasket “deteriorating and wrapped in peeling tape” and a washroom in “a filthy condition with damaged tiles and standing water.” FDA closed that action in 2023 — less than three years before inspectors found the same failure categories again.
Without a lifecycle management program, corrective action becomes repair-until-inspection rather than sustained compliance. ICH Q7 Section 5 requires equipment be maintained in a state that prevents cross-contamination. A closeout letter confirms FDA was satisfied when it reviewed your response. That’s not the same as confirming your maintenance program will hold.
Import Alert 66-40 placed Alchymars on detention-without-examination status on May 19, 2026. The firm is also delinquent on its GDUFA annual facility fee, barring citation of the facility in certain U.S. regulatory submissions. Worth auditing your API supplier qualification records this quarter if Alchymars appears on any active filing.
— Rebecca Lauren