The US FDA released a warning letter for Akron’s Somerset, New Jersey manufacturing facility due to the violations of cGMP. The letter included all the observations the FDA inspection team made during their one-month inspection last month.
The main concern raised by the FDA was about the site’s quality system. The system was not found to be adequate in ensuring the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs. This also led to the collapse of the agreement between Akron and Fresenius Kabi.
The letter also noted that the investigation of the root causes into product defects was not adequately done by Akron. Akron’s Illinois site also received a warning letter in last January for inadequate controls for manufacturing sterile drugs and other violations. The FDA now expects that the executive management of Akron will take necessary steps to resolve all the deficiencies and ensure cGMP compliance.
Mr Vinod Arora, Principal Advisor, IGMPI
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