Its not just the big players who are mired in regulatory troubles with the U.S. Food and Drug Administration. In February, two unlisted Indian companies got warning letters from the regulator on issues identified in manufacturing practices.
Mumbai's USV Limited's Govandi facility was inspected by the USFDA between June 7 and 11, 2013. The warning letter listed issues with laboratory control mechanisms and issues with authorized personnel handling records.
“The lack of reliability and accuracy of data generated by your firm is a serious (manufacturing) deficiency that raises concern for all data generated by your firm,” the USFDA said in the letter.
They added that, “While we acknowledge the commitment in your response that your staff is being interviewed to determine the extent of the problematic laboratory activities, we remain concerned about the capability and credibility of your quality unit.”
USV ranks in the top-20 companies in India, based on AIOCD AWACS data for February 2014. The company, which has four production facilities, said it had sales of Rs 17.57 billion in FY14. The 52-year-old company began as a joint venture with cosmetic giant Revlon's subsidiary USV&P Inc. It manufactures active pharmaceutical ingredients (APIs), peptides, biosimilars, injectables, ophthalmics and solid orals.
Separately, the regulator also hauled up Gujarat-based Canton Laboratories Private Limited citing deficiencies observed in its Vadodara facility. The USFDA raised four issues ranging from issues identified in laboratory testing, inadequate maintenance of data from tests conducted, and unsatisfactory cleanliness of equipment.
“Specifically, during three separate walk-throughs of the facility taking place over five days, our inspection found what appeared to be product residue in the (equipment) despite the “clean” label on the equipment. This represents a potential for cross-contamination of the APIs manufactured in this equipment,” the USFDA noted in the letter dated Feb 27.
The regulator said that the inspection also revealed serious documentation practices and reported missing raw data and that the highlighted examples showing deficiencies, “raise serious concerns regarding the integrity, reliability and accuracy of the data generated and available at your facility.”
Both the companies were told to provide, within 15 days of receipt of the warning letter, specific steps taken to correct and prevent the recurrence of deviations with supporting documentation.