GLOVERSVILLE - It's unclear what's planned for the former Ohm Laboratories location on West Fulton Street after its closure, but it definitely won't reopen before its parent company, Ranbaxy Laboratories, satisfies requirements of a proposed settlement addressing U.S. Food and Drug Administration concerns.
The local Ohm Laboratories manufacturing site closed in October, displacing 15 employees, but the company maintains its larger sites for generic drug manufacturing in North Brunswick and New Brunswick, N.J.
Company spokesman Charles M. Caprariello said the company is keeping its options open for the Gloversville site, which was tagged after a 2009 inspection by the FDA, and mentioned in a consent decree filed on Wednesday by the U.S. Department of Justice on behalf of the FDA.
"At this point, I really can't comment. We have no immediate plans [for the site] and we're always evaluating all of our possibilities," Caprariello said. "Some of our processes and procedures, the FDA questioned, and we looked at it and said, we're probably better off in [this] situation [if] we close the doors on it for right now, and our possibilities will be explored at a later date."
According to the Fulton County Tax Map, the property - including the 33,000 square-foot building, has a 2011 total tentative assessment of $358,200.
Ohm was acquired in 2002 by Ranbaxy Laboratories, which is India's largest pharmaceutical manufacturing company.
A Dec. 21, 2009, warning letter from the U.S. Food and Drug Administration cited issues in a 23-page report with procedures at the Gloversville manufacturing site where liquid pharmaceuticals were made.
According to a complaint for permanent injunction filed in the U.S. District Court for the District of Maryland, an FDA inspection from July 13 to Aug. 12, 2009, at the Gloversville location revealed a failure to investigate batches to make sure they met specifications.
According to the consent decree, which is still subject to court approval, Ranbaxy, and its subsidiary Ranbaxy Inc., which is headquartered in Princeton, N.J., were experiencing problems with "good manufacturing practice" and "data integrity" at the company's facilities at Paonta
Sahib, Batamandi and Dewas in India. The Ohm Laboratories facility in the city also was listed, but the two in New Jersey were not.
Ranbaxy announced in December it had signed the consent decree and was taking necessary steps to fix problems outlined by the FDA - such as falsifying information on drug applications.
The company agreed to relinquish any 180-day marketing exclusivity it might have had for three unnamed pending generic drug applications, and it has agreed to give up exclusivity for several other generic drug applications if decree requirements go unmet by specific deadlines.
If the company submits any falsified drug applications, it agrees to pay up to $3 million for each statement.
The company announced in December it would make a $500 million provision in hopes of resolving all potential civil and criminal liability.
The decree calls for liquidated damages of $15,000 for each day the law is violated.
"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy's history," Ranbaxy CEO and Managing Director Arun Sawhney said in a news release. "While we were disappointed by the conduct that led to the FDA's investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes.
According to court documents, the company failed to establish and follow an "adequate" written testing program at the Gloversville facility to determine appropriate drug storage conditions and expiration dates.
Court documents also state the FDA found the Gloversville facility failed to establish laboratory control procedures.
In addition to other procedural faults, the FDA also said the company failed to have the adequate number of qualified people to supervise, perform, manufacture, process and pack the products. Another fault the FDA noted was failure to use equipment routinely inspected and checked under to a written program to assure proper performance, according to court documents.
According to a news release from the FDA, the three facilities in India were on import alert since 2008, and since the facility in Gloversville closed, "the public should not be concerned that any drugs from those facilities are currently in the U.S. market."
The consent decree outlines detailed data integrity provisions required to be met before the FDA will again review drug applications from the three India facilities. If Ranbaxy wants to reopen its Ohm site in the city, it must comply with a set of requirements in the proposed settlement.
The company must hire an outside expert for a thorough internal review of the facilities, according to the news release from the FDA.
It must also "implement procedures and controls sufficient to ensure data integrity in the company's drug applications and withdraw any application found to contain untrue statements of material fact and/or a pattern or practice of data irregularities that could affect approval of the application," according to the news release.
Amanda Whistle covers Gloversville news. She can be reached at gloversville@leaderherald.com.
