FDA Warns Lake Forest-Based Generic Drug Company Akorn, Inc. About Unsterile Distribution Processes at Plants

Manufacturing problems involving quality and aseptic technique at Akorn Inc.’s New Jersey plant “pose a risk to patients,” according to U.S. Food & Drug Administration (FDA) regulators. The Lake Forest, Illinois-based generic drug manufacturer received a warning letter delivered directly to Akorn Chief Executive Douglas Boothe on June 13, 2019. The letter was posted Tuesday July 09, 2019 on the FDA website. The FDA cited a pattern of manufacturing practice at its Somerset, New Jersey facility that included ignoring quality tests, and drugs failing to meet U.S. standards. The letter also said Akorn workers didn’t take proper precautions to ensure a sterile environment while making treatment drugs, including the pain reliever lidocaine.

Problems cited included a problem with the filling line of ketorolac tromethamine ophthalmic solution, 0.5%, lot 6C95A which were found with product defects including low volume, product leakage, and residue under the neckband. The FDA cited that Akorn’s investigation of the cause of the product defect was inadequate. An FDA inspection discovered use of non-integral containers that posed a significant risk of non-sterility and can also impact chemical attributes of drug products. The FDA also cited that Akorn continued to release drug products manufactured on the problematic filling line.

The FDA also cited an inadequate internal investigation after Akron personnel discovered metal shavings on aseptic filling equipment during the filling of lidocaine hydrochloride 2% jelly, USP Sterile, lots 8E47B and 8E47C.

The FDA cited that operators repeatedly displayed multiple poor aseptic practices during set-up and filling operations of lidocaine hydrochloride 2% jelly, USP Sterile, lot 8G37A.

Without sanitizing their hands, an operator performed an aseptic connection on the fill line. Another operator crouched to wipe the bottom of their foot with plastic wrap. Without sanitizing their hands, the same operator connected a new tank to the fill line.

Sterile lidocaine hydrochloride 2% jelly leaked onto the floor during set-up and filling operations. Filling continued as operators attempted to clean up the spilled product by placing wipes and other materials over the area with their feet. Aseptic connections were made directly above the spilled product.

The FDA cited that leaks of sterilized product and unsecure connections increase the risk of product contamination.

The FDA also cited that aseptic filling equipment design, room space, protection of the area and filling equipment where connections are made, and the number of personnel present during filling operations are deficient. The basic design deficiencies and manually intensive interventions in Akorn’s operation undermine the ability to maintain asepsis, according to the FDA.

There were also distribution problems involving azelastine hydrochloride ophthalmic solution, 0.05% and ciprofloxacin ophthalmic solution, 0.3%. Akron halted distribution and activated recalls of these products.

The FDA also cited inadequate master control records and backup records of laboratory instruments. FDA inspections found that data could be deleted and altered from laboratory instruments, such as the Fourier transform infrared spectrometer (FTIR), total organic carbon, and particle size analyzer instruments. Also, laboratory records failed to include signatures — a required procedure to ensure completeness, accuracy, and compliance of laboratory data.

In January 2019, Akorn was also issued a warning letter for manufacturing violations at its Decatur, Illinois plant.

Akorn’s headquarters in Lake Forest in Lake County is located in a corporate office complex at 1925 West Field Ct just northeast of the I-94 and Route 60 interchange.

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