# FDA 483 - June R.R. Nichols, Ocularist, Ltd - April 11, 2025

Source: https://www.keypedia.com/records/483/june-rr-nichols-ocularist-ltd/e2cb9bb4-09c3-410c-bc0b-0265debf97f0

> FDA 483 for June R.R. Nichols, Ocularist, Ltd on April 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: June R.R. Nichols, Ocularist, Ltd
- Inspection Date: 2025-04-11
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of June R.R. Nichols, Ocularist, Ltd, a manufacturer of Class 2 Scleral Shells, identified two significant quality system deficiencies. The firm failed to establish procedures for quality audits, with the president responsible for all matters also conducting internal audits, which violates regulations. Additionally, the company lacked established and implemented procedures for management review.

## Related Officers

- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/june-rr-nichols-ocularist-ltd/b62a9844-5de6-4106-ae66-6e3ff8ede35c

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669