Pharmalucence issued with FDA warning letter

In April the FDA conducted its biennial inspection and follwing this it has sought to initiate changes at Pharmalucence’s manufacturing facility in Bedford, Massachusetts to resolve alleged deviations from cGMP.

Pharmalucence performs contract manufacturing from the site, covering aseptic fill and finish and formulation services, in addition to providing nuclear imaging products and blood irradiation.

One shortcoming according to the FDA inspectors was the lack of an established procedure to prevent microbiological contamination. In particular the warning letter claims that bacterial filtration retention validation was not performed.

Pharmalucence responded to the initial allegations that were issued prior to the warning letter, stating that it intends to perform the validation but not giving a timeframe.

In the same response Pharmalucence did not indicate that it would stop shipping any products manufactured without a validated sterilisation process. The FDA’s warning letter calls on the company to state if it intends to ship any products manufactured under these conditions and justify its actions.

Further concerns were raised regarding the alleged failure of Pharmalucence’s quality control unit to investigate thoroughly unexplained discrepancies.

The FDA’s warning letter also cites alleged deficiencies in the process to ensure drug product containers are clean, sterilised, and processed to remove pyrogenic properties.

Allegations were also made that Pharmalucence failed to ensure that personnel wore appropriate protective apparel and failed to maintain buildings in a good state of repair.

In email correspondence Glenn Alto, CEO at Pharmalucence, said that the company had issued its response to the FDA’s warning letter on October 14.