Amgen Warned on Contractor, Design Validation Issues

Amgen could not certify to an FDA inspector that it had evaluated a contractor that serviced its equipment, according to a recent warning letter.

The company’s procedures for purchasing controls require it to evaluate, monitor and approve contractors, according to the Jan. 27 letter posted recently online.

Following the inspection, Amgen told the FDA it would ensure service providers conducting preventive maintenance for its X-ray equipment “are evaluated and maintained to the appropriate quality standard.” However, the company did not describe how it will train employees on the new procedures or state whether it will review records to check that current suppliers, contractors and consultants have been evaluated, the letter says.

The warning letter was handed to Amgen’s Thousand Oaks, Calif., facility following a June 4-17, 2013, inspection. The plant manufactures combination products.

The facility was also rapped for a couple of design-related violations. For example, plant employees did not follow the design validation procedure when Prolia (denosumab) was commercially released in 2010 before conducting design validation of the device part of the combination product.

“Amgen takes the observations seriously and has made changes to its procedures in response to the letter,” spokeswoman Ashleigh Koss said.

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