# FDA 483 - Precision Optics Corporation, Inc. - September 11, 2025

Source: https://www.globalkeysolutions.net/records/483/precision-optics-corporation-inc/899d2716-60ef-4bb9-860b-7ffbd45f3630

> FDA 483 for Precision Optics Corporation, Inc. on September 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Optics Corporation, Inc.
- Inspection Date: 2025-09-11
- Product Type: device
- Office Name: New England District Office
- Summary: Precision Optics Corporation, Inc. in Gardner, MA, received a Form FDA-483 with six observations following an inspection of their medical device facility. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning control of nonconforming product, corrective and preventive actions, supplier controls, device history records, complaint handling, and product identification for their ophthalmic laser endoscopes. These issues indicate a lack of established and followed procedures across several critical manufacturing and quality processes.

## Related Documents

- [483 - 2023-03-31](https://www.globalkeysolutions.net/records/483/precision-optics-corporation-inc/ed357925-624d-407d-8e66-62604890b291)

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/precision-optics-corporation-inc/5a86ef51-32c7-40f8-8f58-f2bf95d19796

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