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# 8 Philips Medical Inspection Observations
- URL: https://www.fdaweb.com/8-philips-medical-inspection-observations/
- Published: 2018-03-06T12:00:00.000Z
- Updated: 2026-09-14T23:27:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140918

FDA has released the FDA-483 issued following a 7/17-8/18/17 inspection at Philips Medical Systems, Cleveland, OH. The eight inspection observations listed [were](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM599185?ref=fdaweb.com): 

- failing to review, evaluate, and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to adequately establish procedures for corrective and preventive action;
- risk analysis is inadequate and incomplete;
- failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to adequately establish procedures for acceptance of incoming product;
- failing to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications; and
- failing to adequately establish procedures for design change.