# FDA 483 - Contacare Ophthalmics & Diagnostics - November 01, 2018

Source: https://www.globalkeysolutions.net/records/483/contacare-ophthalmics-diagnostics/a5c9992d-5e9d-4349-a426-d82d3727f4d4

> FDA 483 for Contacare Ophthalmics & Diagnostics on November 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contacare Ophthalmics & Diagnostics
- Inspection Date: 2018-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Contacare Ophthalmics & Diagnostics, a sterile drug manufacturer in Dabhasa, India, was cited for significant deficiencies in its aseptic processing, environmental monitoring, and quality control systems. The inspection revealed failures in personnel monitoring, media fills, sterility testing investigations, cleaning procedures, and validation of sterilization processes. Additionally, issues with complaint handling, documentation practices, and computer system controls indicate a broad lack of adherence to cGMP requirements, posing a high risk to product sterility and data integrity.

## Related Documents

- [483 - 2018-11-01](https://www.globalkeysolutions.net/records/483/contacare-ophthalmics-diagnostics/81e0e8b1-244b-4ad0-9ecd-f9cfd4fe658a)
- [WARNING_LETTER - 2018-11-01](https://www.globalkeysolutions.net/records/warning_letter/contacare-ophthalmics-diagnostics/fc60b7bb-b40d-43d7-898a-58658e4dc6db)

## Related Officers

- [June P. Page](https://www.globalkeysolutions.net/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)

Company: https://www.globalkeysolutions.net/companies/contacare-ophthalmics-diagnostics/069da802-0ebb-4d3a-b872-db4166bde6d6

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1