483
Rocky Mountain Research, Inc.FDA 483 - Rocky Mountain Research, Inc. - July 16, 2019
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Rocky Mountain Research, Inc., a medical device manufacturer in Park City, UT, received a Form FDA-483 with three observations. The inspection revealed deficiencies in documenting the effectiveness of corrective actions, establishing adequate procedures for verifying servicing requirements, and ensuring independence in quality audits. These issues indicate a need for improved quality system controls at the facility.
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