Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.
The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.
In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
Altaire instigates voluntary recall of sterile ophthalmic treatments, after concerns were raised about QA processes in place at its manufacturing facility.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
The US FDA is set to center its drug compounding regulatory program in an office focused on stopping poor quality, unsafe and ineffective drugs reaching patients.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.
The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.
The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
Akorn announces fraud case launched by Fresenius has been denied by US courts, shortly after fourth quarter financials revealed problems within its manufacturing network.
US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
The company’s anticoagulant reversal treatment received a complete response letter from the FDA in 2016 but will be made available today after its approval.