# FDA 483 - Isomedix Operations, Inc. - October 29, 2018

Source: https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/3928f2a8-8ce4-41e4-a407-67b01be6a26c

> FDA 483 for Isomedix Operations, Inc. on October 29, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations, Inc.
- Inspection Date: 2018-10-29
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Isomedix Operations, Inc. in Whippany, NJ, from October 23-29, 2018, identified one observation related to facility and equipment systems. The firm was cited for not maintaining written records of major equipment maintenance and use in individual equipment logs. This indicates a minor deficiency in record-keeping practices for critical equipment.

## Related Officers

- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)

Company: https://www.globalkeysolutions.net/companies/isomedix-operations-inc/5f26b9e8-6a57-4357-aac0-a61636f11bfe

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248