Contract Manufacturer Cited for Complaints, Process Controls

September 18, 2020

The FDA has found lax procedures for handling complaints as well as other quality shortfalls during an inspection of contract manufacturer LH Medical’s Fort Wayne, Ind., facility.

The agency’s investigator observed that 54 of 94 complaints received in 2019 didn’t include the date of the investigation or the reason that the adverse events were deemed not reportable to the FDA.

Product acceptance activities were also found lacking, as 13 of 14 parts failed inspection as oversized, but the same FDA document said they were rechecked and found to be acceptable without further explanation.

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