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

Source: https://www.keypedia.com/records/483/contacare-ophthalmics-diagnostics/81e0e8b1-244b-4ad0-9ecd-f9cfd4fe658a

> 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 Scientific Investigations
- Summary: The FDA conducted an inspection of Contacare Ophthalmics & Diagnostics, a sterile drug manufacturer in Dabhasa, Gujarat, India, from October 25 to November 1, 2018. The inspection revealed significant deficiencies indicating a lack of adherence to Current Good Manufacturing Practices (CGMP) for sterile drug production. Key violations included systemic failures in aseptic processing controls, such as inadequate environmental and personnel monitoring, improper sanitization and gowning procedures, and poor cleaning and disinfection practices within sterile areas. Inspectors noted visibly discolored HEPA filters, rust on filling machines, and critical gaps in barriers separating sterile zones. Furthermore, the firm failed to adequately validate sterilization processes, evidenced by insufficient incubation periods for biological indicators. Critical quality system breakdowns were also observed, including the failure to investigate multiple sterility failures and out-of-specification results, a lack of documented complaints, and deficiencies in data integrity, such as shared login credentials for laboratory instruments and uninvestigated deletion of electronic files. Documentation practices were found to be lacking, with procedures not being recorded at the time of performance. Contacare Ophthalmics & Diagnostics is required to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure the sterility, quality, and purity of its drug products and to comply with FDA regulations.

## Related Documents

- [483 - 2018-11-01](https://www.keypedia.com/records/483/contacare-ophthalmics-diagnostics/a5c9992d-5e9d-4349-a426-d82d3727f4d4)
- [WARNING_LETTER - 2018-11-01](https://www.keypedia.com/records/warning_letter/contacare-ophthalmics-diagnostics/fc60b7bb-b40d-43d7-898a-58658e4dc6db)

## Related Officers

- [June P. Page](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)
- [CEO](https://www.keypedia.com/people/dave-jagrat/e55a233f-318a-4337-8285-d3ec317e0200)

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

Office: https://www.keypedia.com/offices/office-of-scientific-investigations/c53ddaca-0613-4f9d-8f84-8113696f359d