# FDA 483 - Optim LLC - May 29, 2025

Source: https://www.keypedia.com/records/483/optim-llc/8e61b158-f3e1-4683-b1fc-bc39e5139194

> FDA 483 for Optim LLC on May 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Optim LLC
- Inspection Date: 2025-05-29
- Product Type: device
- Office Name: New England District Office
- Summary: Optim LLC, a manufacturer of nasopharyngoscopes in Sturbridge, MA, received two observations during an FDA inspection. The firm was cited for deficiencies in its design history files, specifically regarding the verification of illumination output for its ENTity XL and ENTity SDXL devices. Additionally, the device history records were found to be incomplete, lacking unique device identifiers and finished device labeling.

## Related Documents

- [483 - 2025-05-29](https://www.keypedia.com/records/483/optim-llc/88307503-9f6b-4cf8-982f-22ebacd1eda5)

## Related Officers

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

Company: https://www.keypedia.com/companies/optim-llc/70fcf768-48ba-4bb3-b22b-a5c3421e1df6

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