FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients that it shipped for use in U.S. drugs.
When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.
It has been more than a year and a half since the FDA issued a warning letter for two plants in India owned by Aarti Drugs. But the drugmaker has yet to meet FDA expectations and so the agency has now put them on an import alert, banning them from shipping products to the U.S.
Having spent the past few months trying to bring standards at its Quebec City vaccine plant in line with FDA expectations, GlaxoSmithKline must now work to satisfy another regulator: Health Canada. The Canadian regulator sent GSK an inspection report late last week and gave the Big Pharma 30 days to come up with a plan to fix the problems faced by the facility.
Thinking it needs to change the spin on the story, an industry group in India has hired a Washington, D.C., consulting firm which is launching a campaign it hopes can do that.
GlaxoSmithKline has said it will recall some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. But the U.K.-based drugmaker didn't decide to take the step until it was publicly chastised by the FDA about the problem in a warning letter.
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.