A team of inspectors from the US Food and Drug Administration (FDA) visited Bayer Pharma AG’s Building W11 in Leverkusen, Germany in January 2017 and ten months later the Agency issued the firm with a warning.
The letter, published today, highlighted significant violations of current good manufacturing practice (cGMP) for finished pharmaceuticals at the plant, located at the firm’s headquarters.
These include issues with the cleaning procedures at the firm, with the FDA finding residue on both equipment exterior surfaces and on manufacturing equipment.
“During the production of your drug product (b)(4), which was in a (b)(4), our investigator observed a (b)(4) residue on the (b)(4) exterior surfaces. Your manufacturing area personnel stated that the residue was probably from a (b)(4) drug product, (b)(4), which was previously processed in the same room,” the Agency said.
“In three different rooms, our investigator observed white residues in and around the (b)(4) of three (b)(4) identified as ‘clean.’ Your cleaning procedure did not include provisions for cleaning (b)(4) in (b)(4).”
As a result, the FDA has asked Bayer for a retrospective review supporting the safety and purity of each batch of product manufactured with the equipment that remain within expiry in the US, along with a plan to assess cleaning procedures, practices, and validations for each piece of manufacturing equipment used for several products.
The German firm was also criticised for failures within its quality control unit, including evidence of discarded training records and discarded automated visual inspection machine parameters.
“In a (b)(4) department office waste bin, our investigators observed discarded forms used to document and set inspection parameters for your automated tablet visual inspection machinery. These parameters are used to accept or reject tablets.” the Agency said, regarding the latter.
Meanwhile, an FDA “investigator observed unreported data from in-process tablet weight checks. You programmed your in-process weight checker not to report values that varied more than (b)(4)% from the tablet target weight.”
According to Bayer’s website, products made at the site include prescription drugs Xarelto (rivaroxaban), Nexavar (sorafenib) and Adalat (nifedipine).
The pharma firm did not respond to a request for more information at the time of going to press.