# FDA 483 - Cdymax (India) Pharma Private Limited - April 25, 2025

Source: https://www.keypedia.com/records/483/cdymax-india-pharma-private-limited/ad76f291-4112-477b-8826-ea0caae6e696

> FDA 483 for Cdymax (India) Pharma Private Limited on April 25, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cdymax (India) Pharma Private Limited
- Inspection Date: 2025-04-25
- Product Type: Drugs
- Office Name: Foreign - CDER (Non-Bioresearch Monitoring)
- Summary: The FDA conducted an inspection of Cydmax (India) Pharma Private Limited, an API manufacturer located in Jigani, Bangalore, India, from April 21 to April 25, 2025. The inspection revealed significant issues in the company's quality management system, particularly concerning the handling of out-of-specification (OOS) results and laboratory incidents.

Key violations included inadequate investigations into unexplained discrepancies and failures of batches to meet specifications. The investigations conducted by the Quality Unit were found to be incomplete, lacking comprehensive root cause analysis, and failing to implement effective Corrective and Preventive Actions (CAPAs). Specifically, the company was observed to classify OOS results as laboratory incidents, invalidate initial data without proper analysis, and perform repeated reanalysis until achieving desirable results.

Examples of these issues included multiple instances where initial OOS results were attributed to sample preparation contamination, leading to invalidation and reanalysis without thorough investigation. CAPAs were often repetitive and ineffective, with refresher training being a common but insufficient response.

The FDA's observations highlight the need for Cydmax to enhance its quality management processes, ensuring thorough root cause analysis and effective CAPAs to address and prevent quality issues. The company is expected to address these deficiencies promptly to comply with regulatory standards and ensure product quality and safety.

## Related Documents

- [483 - 2019-05-17](https://www.keypedia.com/records/483/cdymax-india-pharma-private-limited/6bebb67d-1710-4855-b96c-9c78b3cbb505)
- [483 - 2025-04-25](https://www.keypedia.com/records/483/cdymax-india-pharma-private-limited/6a4e0715-7b86-4b4f-9b03-429b9b408bdd)
- [483 - 2025-04-21](https://www.keypedia.com/records/483/cdymax-india-pharma-private-limited/4f789568-92b1-481f-94fa-3cf55a8993d3)
- [483 - 2025-04-21](https://www.keypedia.com/records/483/cdymax-india-pharma-private-limited/0d670442-e628-444c-b143-868c0109e677)
- [WARNING_LETTER - 2025-04-25](https://www.keypedia.com/records/warning_letter/cdymax-india-pharma-private-limited/5483d583-5418-4d4b-8801-ace48e9e8d53)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Arsen Karpetvan](https://www.keypedia.com/people/arsen-karpetvan/ebb53b85-3dad-40ef-b386-1a3a0bae57cb)

Company: https://www.keypedia.com/companies/cdymax-india-pharma-private-limited/51bc8d84-9900-43c0-8e1c-9d2bd08b0ac4

Office: https://www.keypedia.com/offices/foreign-cder-non-bioresearch-monitoring/279f5818-f62e-40c9-951c-cfbc7f929fa1