A generics maker in the U.K. had its manufacturing certification pulled after regulators found data reporting issues.
According to the European Medicines Agency, the action against Bristol Laboratories was taken following an inspection of the company’s facility in Luton in July. The company, founded in 1997, produces a portfolio of generic and over-the-counter, non-sterile capsules and tablets that it sells in the U.K. and Europe.
U.K. regulators provided few details about the issues uncovered, saying that there were two critical deficiencies relating to the integrity and recording of GMP critical data as well as issues with the facility’s ongoing stability-monitoring program.
Authorities withdrew the plant’s GMP certificate, but issued a restricted certificate that allows the facility to continue producing any products considered medically critical to EU members.
Bristol Laboratories is not the only U.K. producer to find itself crosswise with regulators in the last year. The FDA sent a warning letter to Wallace Cameron, located in Wishaw, Scotland, in October 2016 saying the drugmaker continued to ship products to the U.S. even though it was no longer registered with the agency.