Philips Gets Second GMP Warning in Two Months

Philips Medical Systems received a warning letter for GMP violations related to its computed tomography and nuclear imaging systems, the second GMP-related warning in two months.

The most recent letter cited several complaint-handling violations, noting the firm classified complaints as “statement[s] expressing dissatisfaction.” The firm did not consider communications as complaints if the customer did not specifically allege dissatisfaction even if they would otherwise qualify as complaints, the letter said.

The FDA found that Philips required only “potential safety events” to have documented rationales for reportability under medical device reporting requirements. Of the 459 complaints the company received from March to August 2007, seven had a documented MDR assessment, the letter said.

Philips also failed to maintain investigation records. Eleven of 28 complaints reviewed by the FDA investigator had incomplete complaint investigations, the letter said.

Philips’ response to the FDA said it has revised complaint-handling methods by creating a template in its complaint tool to ensure documentation of investigations is adequately maintained.