# FDA 483 - Ophthalmic Labs, Inc. - April 09, 2024

Source: https://www.globalkeysolutions.net/records/483/ophthalmic-labs-inc/68eeeb97-1744-48a5-a24d-369540abb1a7

> FDA 483 for Ophthalmic Labs, Inc. on April 09, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ophthalmic Labs, Inc.
- Inspection Date: 2024-04-09
- Product Type: device
- Office Name: New England District Office
- Summary: Ophthalmic Labs, Inc. in Milton, MA, a medical device manufacturer, received a Form FDA 483 following an inspection that revealed significant deficiencies in its quality system. The inspection cited inadequate complaint handling procedures, failure to submit required device information to the Global Unique Device Identification Database (GUDID), and a lack of established servicing procedures. These observations indicate a need for improved controls in managing device complaints, ensuring proper device identification, and maintaining service records for their (b)(4) software program.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.globalkeysolutions.net/companies/ophthalmic-labs-inc/721fc841-ec5e-4604-b796-bd9b1b499471

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