The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
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.
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.
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.
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 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.
Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.
