# FDA 483 - Integrated Ophthalmic Systems, Inc - December 15, 2021

Source: https://www.globalkeysolutions.net/records/483/integrated-ophthalmic-systems-inc/b2926085-41c4-43cf-9fbc-aa41cad65020

> FDA 483 for Integrated Ophthalmic Systems, Inc on December 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integrated Ophthalmic Systems, Inc
- Inspection Date: 2021-12-15
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Integrated Ophthalmic Systems, Inc. in Woburn, MA, was inspected by the FDA, revealing two significant issues. The firm failed to establish and implement adequate procedures for electronic Medical Device Reporting (MDR) and lacked sufficiently defined procedures for design validation, specifically regarding code reviews and defect tracking. These observations indicate deficiencies in the firm's quality system for medical device manufacturing.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/integrated-ophthalmic-systems-inc/97ac1747-1ee5-4f0a-bbd0-5acd1dcbdcc1

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7