# FDA WARNING_LETTER - Philips Medical Systems (Cleveland) Inc - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/philips-medical-systems-cleveland-inc/d54511a7-f934-455f-bd29-927a6c8cef65

> FDA WARNING_LETTER for Philips Medical Systems (Cleveland) Inc on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Philips Medical Systems (Cleveland) Inc
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On June 7, 2011, the FDA issued a Warning Letter to Philips Medical Systems (Cleveland) Inc. following an inspection from August 25 to December 3, 2010. The inspection revealed that the firm's Brilliance, Big Bore, iCT, MX-16 Slice Families of CT products, and Gemini, Gemini LXL/TF, BrightView, JetStream, and Precedence Families of NM products were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: Issues like incorrect HCOR Scaling for infant scans were not managed through the CAPA system, leading to delayed implementation of fixes.
2.  **Failure to implement and record changes for quality problems (21 CFR 820.100(a)(5))**: The firm continued using unbaked anode/cathode power modules despite identified moisture ingress and a supplier's corrective action.
3.  **Failure to investigate nonconformities (21 CFR 820.100(a)(2))**: CAPA 10-0

## Related Officers

- [Mark E. Parmon](https://www.keypedia.com/people/mark-e-parmon/acada198-6b46-47de-a605-51cec0af2d15)
- [Joseph A. Vinhais](https://www.keypedia.com/people/joseph-a-vinhais/af1fe986-56f9-41eb-98df-08f77364a7e6)
- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/philips-medical-systems-cleveland-inc/f9428826-00c7-4fcc-b721-7bf5737e29eb

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861