Pomerantz LLP is investigating claims on behalf of investors of Akorn, Inc. ("Akorn" or the "Company").
The investigation concerns whether Akorn and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
On January 9, 2019, Akorn disclosed that it received a warning letter from the U.S. Food and Drug Administration, after the company's Decatur, Illinois manufacturing facility was inspected by the regulatory authority in April and May 2018. In particular, the FDA found that the Company (1) "failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b))"; (2)"failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10))"; and (3) "failed to follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a))."
Following this announcement, Akorn's stock price fell sharply during intraday trading on January 9, 2019.