# FDA 483 - Comar Inc. - April 18, 2024

Source: https://www.keypedia.com/records/483/comar-inc/a454964b-ac2e-491c-a685-08a14229820e

> FDA 483 for Comar Inc. on April 18, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Comar Inc.
- Inspection Date: 2024-04-18
- Product Type: other
- Office Name: New Jersey District Office
- Summary: Comar Inc. in Buena, NJ, a contract manufacturer, received a Form FDA 483 with four observations during an inspection from April 15-18, 2024. The observations primarily concern inadequate quality system procedures, including issues with corrective and preventive actions, process controls, environmental monitoring in cleanrooms, and employee training documentation. These findings indicate significant deficiencies in the firm's quality management system.

## Related Officers

- [Jonathan Ho](https://www.keypedia.com/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)
- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)
- [Nakesh N. Gomanie](https://www.keypedia.com/people/nakesh-n-gomanie/cfffa8e1-fdfb-4bc4-a845-44bcd593c9c7)

Company: https://www.keypedia.com/companies/comar-inc/955ea0a4-0a00-49c6-a889-f6640fd12fc1

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