# FDA 483 - Center For Ocular Prosthetics, LLC - March 07, 2022

Source: https://www.keypedia.com/records/483/center-for-ocular-prosthetics-llc/20626e62-01af-4b64-bb18-276b731c5f4b

> FDA 483 for Center For Ocular Prosthetics, LLC on March 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Center For Ocular Prosthetics, LLC
- Inspection Date: 2022-03-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: This FDA Form 483 was issued to Center For Ocular Prosthetics, LLC in Portland, OR, following an inspection from March 4-7, 2022. The inspection revealed significant deficiencies across multiple quality system areas, indicating a lack of fundamental procedures for complaint handling, corrective actions, medical device reporting, and record keeping. The firm failed to establish and implement essential quality system procedures for its ocular prosthesis devices.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/center-for-ocular-prosthetics-llc/68254fee-6418-4f83-916f-ad0f8c36d8c2

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822