# FDA 483 - Precision Optics Corporation, Inc. - March 31, 2023

Source: https://www.keypedia.com/records/483/precision-optics-corporation-inc/ed357925-624d-407d-8e66-62604890b291

> FDA 483 for Precision Optics Corporation, Inc. on March 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Optics Corporation, Inc.
- Inspection Date: 2023-03-31
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Precision Optics Corporation, Inc. in Gardner, MA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling complaints, managing rework of nonconforming products, and implementing corrective and preventive actions. These issues indicate a lack of robust control over critical quality processes.

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## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94