Tag:
FDA Warning Letter
Latest Headlines
Latest Headlines
FDA cites Boehringer Ingelheim plant in Germany
Just months after signing a consent decree for the manufacturing mess in its Ben Venue subsidiary, Boehringer Ingelheim finds itself on the firing line with the FDA again, this time for particle contamination in an API produced 4 and 5 years ago.
FDA nails Pfizer plant for contaminated Torisel diluent
In 2011 when serious manufacturing issues surfaced at the Ben Venue plant in Ohio, Pfizer ($PFE) decided to dump it as a supplier for its diluting agent for the cancer drug Torisel. In fact, Pfizer said it had an exit strategy for all of the drugs being made by the Boehringer Ingelheim unit.
UPDATED: Warning letter details contamination of Alexion's Soliris API
Late last month, Alexion Pharmaceuticals ($ALXN) assured investors it was on top of the issues with its pricey rare-disease drug Soliris. But the FDA report indicates that Alexion has had trouble figuring out the source of the contamination and so adequately attacking it.
FDA lifts ban on some Aurobindo antibiotics
For two years, the FDA has banned all of the drugs made at an Aurobindo Pharma antibiotics plants in Hyderabad, India, after inspectors found problems with contamination reporting. The India company now reports it is partially out of the woods with regulators.
Form 483 lays out latest issues dragging down Hospira
The FDA has now posted its inspection report for Hospira's problem-plagued Rocky Mount, NC, plant, and it does not paint a pretty picture for a company that has spent hundreds of millions of dollars and more than a year of consulting time trying to get its manufacturing in order.
Impax handed 12-page 483 at reevaluation
Impax Laboratories' struggles to get its manufacturing practices down at a plant in California where it intends to produce Rytary, an extended-release Parkinson drug, persist, the company has confessed. In fact, after reinspection of the plant, Impax received a Form 483 with a dozen observations, three of them repeats.
FDA picks apart processes at Jubilant HollisterStier plant
Jubilant HollisterStier picked up some work recently when the maker of imaging agents needed to move production away from the beleaguered Ben Venue plant in Bedford, OH. Turns out Jubilant HollisterStier is having some issues of its own at a plant in Canada.
FDA lambastes Jamaican manufacturer over sterility, quality
The FDA has come down on a drugmaker in Kingston, Jamaica, that it says is coming up short in manufacturing standards and ensuring sterility.
CDMO Sovereign takes it on the chin in FDA warning letter
The FDA has found issues with a plant operated by contract manufacturer Sovereign Pharmaceuticals, saying the plant is not only having problems with its GMP manufacturing but also is producing over-the-counter meds that don't qualify for that category.
FDA nails Novo for missing 850 samples over 2 years
While most of the discussion of stepped-up inspections by the FDA of foreign manufacturing plants is about the need to keep track of China, it does not mean the industry's biggest players will escape tough oversight. The FDA has sent a scathing warning letter to Novo Nordisk about a plant in Denmark.
