Last year, FDA inspectors said employees at the Canton Laboratories active pharmaceutical ingredient facility in Vadodara, India, were not getting equipment clean enough between batches to prevent cross contamination. The company's certificates of analysis had been showing that its APIs were within limits for microbial and metal content, but there was a problem with those tests: They never occurred.
Baxter International, which has faced FDA criticism for operations at some of its plants, is recalling 5 lots of products after particulate was found in two different solutions.
When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
When AMRI bought Hyaluron in June 2010, it enjoyed a brief, two-month honeymoon before the FDA slapped the acquired sterile syringe and vial filling plant with a warning letter. The hangover has lasted three years, but now the agency has finally issued a letter to close out the failings it found at the Burlington site.
Some Indian drugmakers have complained about failing infrastructure that leaves power and water supplies uncertain in that country, creating obstacles for manufacturing. A recent warning letter to an API maker in Mumbai illustrates the impact that can have.
German drugmaker Fresenius received a scathing warning letter in July for a drug plant in India. Now, a blood-products plant in Puerto Rico has been sent a warning for a labeling issue which the agency said should have been resolved months, even years ago.
In a warning letter, the FDA has chastised the management of an Agila Specialties plant in India that Mylan ($MYL) is buying from Strides Arcolab for using defective gloves in the aseptic processing area and then not taking the problems seriously enough.
An FDA warning letter to Indian drugmaker Posh Chemicals says that a quality-control chemist admitted during a March inspection that he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager.
Hospira rebounded from losses and reported a second-quarter profit, yet the drug and device maker has revealed that its work to improve quality-control issues at plants across the world is far from over.
The only good part of receiving an FDA warning letter is when a company gets a closeout letter that says it has finally met FDA expectations. It has taken three years, but generics maker CorePharma says it has gotten its closeout for a plant in New Jersey.