The FDA has chastised a pair of India-based API manufacturers in separate warning letters outlining poor record keeping, problems maintaining sanitation and licensing issues, among other observations.
The U.S. regulatory agency inspected Almon Healthcare’s Ahmedabad, India, facility in February and said it found “significant deviations” that have resulted in the latest reprimand.
During the inspection, the agency noted the company failed to do identity testing on raw materials used to produce active pharmaceutical ingredients (API) that were ultimately bound for use in pharmacy compounding.
The company "intentionally accepted lots of" of a redacted material "that were deliberately mislabeled by your supplier,” the FDA said in its letter to Almon, dated July 13. “ Your [quality unit] admitted that this was a deliberate and ongoing practice since 2024 to circumvent you firm’s lack of a required license.”
The mislabeled and untested material was used to produce batches that were then shipped to the U.S., the agency added.
Almon was also slammed in the letter for lackluster efforts to confirm that all of its testing procedures were scientifically sound and appropriate to ensure its intermediates and API conform to regulatory standards.
The FDA also found that the company didn’t adequately clean non-dedicated API production equipment used to manufacture an undisclosed number of different APIs. An inspector saw contaminates on product contact surfaces and an unspecified liquid draining from a container, although the equipment had been documented as “empty and cleaned.”
In the case of Shimoga Chemicals and its facility in the Indian state of Maharashtra, the FDA issued a warning letter, also dated July 13, covering an inspection held at the site between January 19-23.
That review resulted in three observations that included failure to implement adequate controls over the site's analytical testing data, subpar process validation and lack of assurance that the companies' drug ingredients are being produced in accordance with Current Good Manufacturing Practices.
The facility churns out clomiphene citrate (Clomid), also intended for U.S. pharmacy compounding to treat female infertility in patients who do not ovulate regularly or at all.
Inspectors found the company lacked proper sampling procedures and records, and Shimoga didn’t perform verification studies for any test methods around the product, either, per the FDA's writeup.
“Your firm failed to verify the residual solvent method used by your contract testing laboratory,” the FDA said. “During the inspection, your QC manager confirmed that no method verification has been performed for any of the test methods used for clomiphene citrate USP.”
The company was also rebuked for sloppy cleaning procedures related to non-dedicated equipment used during the production of clomiphene citrate.