Daiichi Sankyo subsidiary gets FDA warning
pharmafile | September 15, 2011 | News story | |Â Â Daiichi Sankyo, FDA, LuitpoldÂ
Daiichi Sankyo’s US subsidiary Luitpold Pharmaceuticals has been sent a warning letter by the FDA for “significant” and repeated quality issues at a plant in New York.
The facility in Shirley, New York, was temporarily shut down in April following an FDA inspection which found a range of violations, including a lack of written procedures for production and process controls, inappropriate analytical methods and failure to complete investigations into defective batches.
One issue the regulator highlighted was the presence of particulate matter in vials of parenteral products made at the plant and sold by the company’s American Regent division. This has been “a persistent and serious issue at your firm for many years”, according to the letter sent to Luitpold president and chief executive Mary Jane Helenek.
Giving an example, the agency said Luitpold failed to carry out a thorough investigation of a potassium phosphate product which showed evidence of visible particles, blaming the defect on glass delamination “without justification”.
Luitpold should include an analysis of the particle contamination and its potential impact on products in its response to the warning letter, it added. There have been around a dozen recalls of American Regent products in the last year because of the presence of particulate matter in vials, as well as other recalls relating to issues such as in-shelf-life potency failure.
FDA officials had raised concerns during inspections in 2008 and 2009, and sent the letter after finding that some of the issues remained unresolved during inspections carried out between 9 February and 15 March of this year.
While Luitpold’s initial response outlined a new investigation process as well as the company’s commitment to re-examine prior investigations, the company had not included or implemented revised procedures, said the FDA.
The company must quickly correct the violations at the plant or face seizure of its products or an injunction, according to the agency.
Products made at the plant and distributed by another Luitpold subsidiary, PharmaForce, are not thought to be affected by the latest action. Luitpold acquired PharmaForce in December 2010.
Phil Taylor
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