483
E-Beam Services, Inc.FDA 483 - E-Beam Services, Inc. - April 27, 2023
Record Details
E-Beam Services, Inc., a medical device sterilizer in Cranbury, NJ, received two observations during an FDA inspection. The findings highlight deficiencies in the firm's record-keeping practices, specifically regarding the lack of detailed descriptions for document changes and incomplete device history records that omit critical processing times for sterilization.
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ID · 4fd67091-cdc3-4150-9a48-e1c91d6acb2c