Topic:
Warning Letters
Latest Headlines
Latest Headlines
Manufacturing issues trip up approval for Gilead, Impax
Once drugs are approved, manufacturing is supposed to kick in and get the product out the door so drugmakers can start making some money. But recently, questions about manufacturing have not only been a stumbling block for some companies to getting approvals, they have broken up a relationship.
Alexion brings in hired guns for troubled plant
When the FDA told Alexion in a warning letter late last month that its quality system at a plant in Rhode Island was not "robust" enough, the agency suggested that Alexion hire experts to help it get on top of the problems there. That is what Alexion has done.
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.
UPDATED: Alexion gets warning letter for Soliris plant
The FDA has issued a warning letter for the plant where Alexion Pharmaceuticals manufactures its pricey rare-disease drug Soliris. The letter has yet to make it to the FDA's website, but the company got ahead of the news by reporting to the SEC that the warning was delivered yesterday.
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 warning to Abbey questions quality of API for sterile drugs
The FDA says an active pharmaceutical ingredient maker in Philadelphia had yet to qualify that its purified water was in fact pure enough to make APIs two years after the agency noted a deficiency.
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.
