Akorn gets FDA warning letter related to New Jersey plant [Reuters (UK)]
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Source: Reuters
Akorn gets FDA warning letter related to New Jersey plant - Reuters 1 Min Read (Reuters) - Akorn Inc said on Tuesday the U.S. Food and Drug Administration has raised certain issues related to its Somerset, New Jersey manufacturing facility, sending the generic drugmaker’s shares down nearly 13% premarket. The FDA warning letter followed an inspection of the plant in July and August last year and is the latest in a series of setbacks for Akorn and comes months after the agency raised concerns about its manufacturing plant in Amityville, New York. In January, Akorn’s manufacturing plant in Decatur, Illinois, received a warning letter after it did not resolve previously highlighted violations such as failure to follow procedures to prevent contamination of drugs produced at the plant. Akron, which said it will work to resolve all issues raised in the agency’s letter, expects to continue production at the Somerset facility. Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shail
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