Summary: The FDA cited Royal Philips for manufacturing violations at its Suzhou, China, facility. Insufficient practices led to adulterated CT and ultrasonography devices due to unvalidated processes and inadequate response to compliance issues.

Key Takeaways:

  • Critical Manufacturing Flaws: Philips faced significant non-compliance in device manufacturing standards.
  • Inadequate Corrective Actions: Philips’ response to FDA findings was deemed insufficient, lacking comprehensive process improvements and training.
  • Potential Impact on Business: The violations could influence Philips’ eligibility for federal contracts and approval of future medical device applications.

During an inspection at Royal Philips‘ manufacturing plant in Suzhou, China, U.S. FDA investigators identified several violations, according to a recent letter from the FDA. The facility produces CT and ultrasonography systems, which are classified as medical devices under the Federal Food, Drug, and Cosmetic Act.

Critical Manufacturing Deficiencies

In the letter, the FDA states that Philips’ devices were found to be non-compliant with the required manufacturing practices. Notably, the Philips Incisive CT Patient Interface Monitor (PIM) data cable had inadequate validation of its injection molding process. This oversight led to 64 customer complaints about cable connection failures, which could delay critical diagnostic procedures by causing ECG gating signal errors.

Insufficient Corrective Measures and Misbranding Issues

The FDA received responses to the violations from the plant’s head of quality. The corrective actions proposed by Philips included placing a hold on the distribution of the problematic PIM data cables and requalifying suppliers. However, these measures were deemed insufficient as they did not fully address all manufacturing processes or ensure comprehensive employee training on the updated protocols.

Additionally, the FDA identified that Philips failed to adequately report several field corrections necessary to mitigate health risks, which constitutes misbranding under federal regulations.

Implications for Compliance and Federal Contracts

The FDA has expressed concerns that these violations could affect Philips’ ability to secure federal contracts and impact the approval of their Class III medical devices. Philips was asked to submit a detailed plan to address these violations, including systemic corrections and a timeline for their implementation.