FDA hands Akorn its fourth 483

Mar 01, 2019

The FDA has issued Akorn a Form 483, following an inspection of the drugmaker's manufacturing plant in New York, just weeks after Akorn received a warning letter for its Illinois site.

The FDA raised concerns about sterile drug manufacturing plant in Amityville, New York, specifically calling into question the facility’s systems for keeping its equipment free from contamination and also noting that containers in the plant were not tested for conformance with written procedures.

The agency highlighted the more than 50 customer complaints that the Lake Forest, Illinois-based drugmaker had received over the last year, related to malfunctions in the spray or dropper of the generic drugmaker's products.

Akorn’s manufacturing plant in Decatur, Illinois, received a warning letter last month after it did not resolve previously highlighted violations such as failure to follow procedures to prevent contamination of drugs produced at the plant. The same plant had previously received 13 observations back in May 2018.

The drugmaker's Somerset, New Jersey plant was issued a 483 back in November, detailing 11 observations on its quality system, laboratory controls and production processes.

Read the Reuters coverage

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