# Gregory Manufacturing, Inc. – FDA 483, Apr 2, 2026

Source: https://www.keypedia.com/records/483/gregory-manufacturing-inc/b1394bbc-fbb8-48b9-9ace-2a4c0738d0bb

> FDA 483 for Gregory Manufacturing, Inc. on April 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gregory Manufacturing, Inc.
- Inspection Date: 2026-04-02
- Product Type: device
- Office Name: New England District Office
- Summary: During an inspection, Gregory Manufacturing, Inc. in Holyoke, MA, was cited for a single observation related to their corrective and preventative action procedures. The firm failed to initiate a corrective action report after mislabeled devices were returned by a customer, which was a requirement under their own written procedures. This indicates a lapse in their quality system regarding nonconformity management.

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/gregory-manufacturing-inc/1b81e669-eda5-4d5b-8be1-44bd3d264bb5

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144