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

Source: https://www.globalkeysolutions.net/records/483/cdymax-india-pharma-private-limited/6a4e0715-7b86-4b4f-9b03-429b9b408bdd

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

---

## Details

- Record Type: 483
- Company Name: Cdymax (India) Pharma Private Limited
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Cydmax (India) Pharma Private Limited, an API manufacturer in Jigani, Bangalore, received a Form 483 with significant observations related to quality control, laboratory practices, and manufacturing controls. The inspection revealed critical issues including inadequate investigations into out-of-specification results, unvalidated test methods, deficient quality unit oversight, and poor contamination control during API manufacturing and equipment cleaning. These findings indicate a systemic lack of adherence to cGMP regulations, posing a risk to product quality and patient safety.

## Related Documents

- [483 - 2019-05-17](https://www.globalkeysolutions.net/records/483/cdymax-india-pharma-private-limited/6bebb67d-1710-4855-b96c-9c78b3cbb505)
- [WARNING_LETTER - 2025-04-25](https://www.globalkeysolutions.net/records/warning_letter/cdymax-india-pharma-private-limited/5483d583-5418-4d4b-8801-ace48e9e8d53)

## Related Officers

- [Arwaa Kampetya](https://www.globalkeysolutions.net/people/arwaa-kampetya/92e30608-2e97-4929-8249-79a315e9715a)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8