- The Food and Drug Administration issued a warning letter to Bayer AG for wide-ranging problems at one of its German manufacturing facilities.
- An inspection of the company's Leverkusen plant in early 2017 identified residue on the outside of non-dedicated equipment that regulators cautioned could lead to cross-contamination. Following the inspection, Bayer tested samples of tablets made in the same room as other drugs and found they had been adulterated — leading to the recall of several lots of product.
- Regulators also noted the site didn't have proper quality control and recordkeeping protocols in place. For example, workers received multiple complaints that some bags containing drug product were leaking. The company-led investigation into the issue never identified the root cause, according to the FDA, and was overall inadequate.
While FDA warning letters have frequently targeted smaller drugmakers based in China and India, big pharma hasn't exactly gone unscathed either.
In September, the agency slapped Pfizer Inc. subsidiary Meridian Medical Technologies Inc. with one, calling the St. Louis-based manufacturer out for quality control issues that didn't meet current good manufacturing practice (CGMP) standards. Regulators also hit a facility in Coppell, Texas with a Form 483 last March, fueling the FDA's decision to reject AstraZeneca's ZS-9, which was being produced there.
Now, Bayer is facing the backlash of non-compliance. Though the German drugmaker crafted its own letter responding to the FDA's original concerns, it's clear the response didn't sit well with U.S. regulators.
"In a . . . 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 FDA wrote in its warning letter.
"In your response, you noted that you documented and approved final set-up parameters, 'but historically the calculations generated in support of those parameters have not been preserved.' You indicate that programming the visual inspection machine to detect defects may not be a CGMP activity. We note that the parameters of this machinery are used to discriminate between acceptable and unacceptable tablets. Accordingly, entering reliable settings into machine programming is part of CGMP."
Bayer's focus, understandably, has turned to getting back in the FDA's good graces — particularly because issues at the plant are gumming up production and have the potential to dampen bottom lines.
"Bayer is fully committed to diligently addressing all items raised by the FDA and to continue the implementation of necessary corrective actions. Comprehensive reports on the progress of these corrective actions have been shared with the agency," the company said in an email to BioPharma Dive.
"Due to the ongoing remediation and also modernization measures at the site, we expect temporary supply limitations affecting our mature product portfolio. The business impact will be reflected in our upcoming 2018 guidance on February 28," Bayer said.