Windlas issued a warning letter by the US FDA after the regulator finds the manufacturer’s response inadequate to justify wrongdoings at its India facility.
After an investigation last year, the FDA cites problems across multiple sites within the Lupin manufacturing network, raising questions about ‘management oversight and control’.
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.
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 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.
The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.
Akorn received a warning letter from the FDA on January 4, relating to the inspection of its manufacturing facility in Decatur, Illinois, in April and May 2018.
According to the US FDA, a facility inspection revealed operators leaned their heads and torsos over open containers while clearing bottle jams, before restarting the aseptic line.
The US FDA has issued a warning letter to contract testing laboratory Pharmaceutical Laboratories and Consultants, Inc., after a microbrewery was found to be operating in shared space.
The US Food and Drug Administration (FDA) has given the go ahead to Frontida BioPharm’s Pennsylvania, US-based site, eight months after distributing a Warning Letter for the facility.
The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.
Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.
Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.
Hospira linked its improved Q2 results to progress made in efforts to address quality problems at various manufacturing plants, but the 483s and Warning Letters are still coming.