Bayer Handed a Form 483 for Training, Lax Procedures

Inadequate GMP training and testing procedures landed pharma giant Bayer a Form 483 after an inspection of its Shawnee, Kan., facility.

During a May inspection, investigators found that the drugmaker’s training program for titration does not “include proficiency and personnel qualifications,” the agency said.

“In 2012 and 2013, there were at least two separate instances when the cause of an out-of-specification investigation was an untrained analyst or analyst not following procedure,” reads the form, which contained six observations.

Both incidents were associated with the benzyl alcohol raw material assay by titration.

Bayer also lacks a procedure to “mitigate mix-ups of differing production data sheets,” the agency said.

For example, an investigator saw batch record pages from five different products on an auditor’s clipboard while in the packaging area for Precose (acarbose) 50 mg tablets.

Bayer responded that it submitted corrective actions to the FDA and “in response received an establishment inspection report from the agency indicating there are … no further issues,” spokeswoman Staci Gouveia told QMN.

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