Synthes plant cited in FDA warning letter
pharmafile | March 8, 2012 | News story | Manufacturing and Production |Â Â FDA, J&J, JJ, Synthes, manufacturingÂ
The US FDA has sent a warning letter to surgical equipment manufacturer Synthes upbraiding it for deficiencies at a manufacturing facility in West Chester, Pennsylvania.
Switzerland-headquartered Synthes is in the process of being acquired by Johnson & Johnson in a $21.3 billion deal, the largest in the firm’s 125-year history and designed to boost its orthopaedic equipment franchise.
J&J is already struggling to cope with its own manufacturing quality problems, particularly in its consumer healthcare operations, so the news that Synthes is carrying similar baggage will not be welcome. Manufacturing issues, recalls and related litigation costs cost the firm more than $2.8 billion last year.
The FDA’s warning letter says that quality unit at Synthes’ West Chester plant was not exercising due diligence in its oversight of a contract manufacturer of parts used in medical devices assembled at the plant, which allowed out-of-specification materials to be released for commercial distribution.
In addition, Synthes failed to follow-up complains about its products properly and in a timely manner, and did not keep complete records of investigations into complaints.
The company also neglected to inform the FDA within 30 days of incidents in which medical devices were reported to have malfunctioned, in a manner that “would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur”, says the letter.
The FDA had also taken issue with Synthes’ procedures for implementing corrective and preventive actions (CAPA), but said the firm’s response to this issue appeared to be adequate.
Synthes has until August 10 to submit a preliminary certification report by an outside consultant to show that it has rectified the deficiencies, and will have to submit an updated certification every six months thereafter. Failure to do so could leave it open to financial penalties.
Phil Taylor
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