# FDA 483 - Cohance Lifesciences Limited - August 12, 2025

Source: https://www.keypedia.com/records/483/cohance-lifesciences-limited/9cd0b950-19a6-468e-856e-dfaa9549128f

> FDA 483 for Cohance Lifesciences Limited on August 12, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cohance Lifesciences Limited
- Inspection Date: 2025-08-12
- Product Type: other
- Office Name: Office of Health Technology 7 (In Vitro Diagnostics)
- Summary: The request specifies the need for a concise summary of an FDA 483 document, targeting a word count between 150 and 300 words. Key elements to be included in this summary are the company name, inspection dates, primary violations or issues identified, the applicable regulatory framework, and any required actions. However, the 'Content' provided for summarization only lists page numbers, from 'Page 1 of 17' through 'Page 17 of 17,' and does not contain any actual textual information from the FDA 483 document itself. Consequently, without the substantive content of the inspection report, it is not possible to extract the specific details regarding the company, the inspection timeline, the nature of observations, the precise regulatory citations, or any mandated corrective measures. To accurately fulfill the summarization request and meet the specified criteria, the complete and detailed text of the FDA 483 document must be supplied.

## Related Documents

- [483 - 2025-08-12](https://www.keypedia.com/records/483/cohance-lifesciences-limited/2e1f88c0-a821-4a1b-a0de-7c2e8743dbad)
- [483 - 2025-10-31](https://www.keypedia.com/records/483/cohance-lifesciences-limited/5d6a0246-5a18-4275-b42c-36e338ead866)
- [WARNING_LETTER - 2025-08-12](https://www.keypedia.com/records/warning_letter/cohance-lifesciences-limited/82d97f9c-aa45-433f-bd29-66a8a005fcff)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/cohance-lifesciences-limited/8d5664bf-2d4e-44f3-abcc-c98c49d62e8a

Office: https://www.keypedia.com/offices/office-of-health-technology-7-in-vitro-diagnostics/19bfc7ca-52e3-49b8-84a6-14d7fd927811