FDA Warns Pennsylvania Drugmaker Over GMP Violations

Posted 26 August 2016 | By Michael Mezher 

FDA Warns Pennsylvania Drugmaker Over GMP Violations

The US Food and Drug Administration (FDA) has warned Frontida BioPharma Inc. for numerous good manufacturing practice (GMP) violations and failing to provide FDA officials with requested information during the course of an inspection.

Warning Letter

The warning letter comes as a result of a month-long inspection of Frontida's Philadelphia facility in June and July last year, when it was owned by Indian drugmaker, Sun Pharmaceutical. Frontida purchased the facility from Sun just two months prior to receiving the warning letter.

During the inspection, FDA says it found evidence the facility knowingly released 27 lots of potentially contaminated drugs.

"Your quality unit knowingly released 27 lots of various strengths of clonidine HCI tablets on or about March 5, 2015, despite evidence that [the] active pharmaceutical ingredient (API) used in their manufacture…was potentially contaminated," FDA writes in the Warning Letter.

Furthermore, FDA says the company's vice president of quality, who was fired during the inspection, "repeatedly denied knowledge [of the recall], even though e-mail evidence collected during the inspection showed that this individual had been notified of the recall as early as July 16, 2014."

FDA says the company also failed to adequately analyze the lots affected by the recall for contamination before eventually releasing them in March 2015.

"You then hired a contract testing laboratory to analyze retain samples of the clonidine API lot for cross contamination. However, your contract laboratory provided documentation that its test method was not validated to detect low levels of cross contamination, and explicitly stated that the test results 'may not be used for batch release,'" FDA writes.

FDA also says the company failed to act when a three-month stability test indicated that a lot of its drugs had an out-of-specification impurity result. Furthermore, FDA says the company was "aware that benzophenone had leached into the tablets from the ink and varnish on the primary container label," but failed to recall the lot until 16 July 2015, one day before the agency finished its inspection.

Lastly, FDA says the company maintained shoddy record-keeping practices, including:

  • Investigation reports containing data and documentation from unrelated investigations
  • Records signed with only a first name
  • Records missing dates; and
  • Illegible entries in logbooks and laboratory notebooks

As a result, FDA says that Frontida must develop a plan to ensure its quality unit fulfills its responsibilities to reject products that fail to meet quality, purity and safety standards; improve its supplier qualification; and "conduct a retrospective evaluation of [its] drug products within expiry."


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