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

Source: https://www.keypedia.com/records/483/cydmax-india-pharma-private-limited/9c5b9ab6-a624-4b52-b41e-42e9331e26c6

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

---

## Details

- Record Type: 483
- Company Name: Cydmax (India) Pharma Private Limited
- Inspection Date: 2025-04-25
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: During a recent inspection, the FDA issued a Form 483 to a company manufacturing the 'Sympto-Therm' software device, detailing 20 significant observations regarding its quality system. The primary deficiency highlighted is the pervasive absence of established procedures across nearly all critical aspects of medical device manufacturing, as required by 21 CFR Part 820, the Quality System Regulation. Key violations include the lack of fundamental design control procedures covering planning, input, output, review, verification, validation, transfer, and changes--a repeat observation from a previous inspection. Similarly, the firm lacks established purchasing controls, failing to evaluate suppliers like its software developer, another recurring issue. Further significant omissions include procedures for handling customer complaints, implementing corrective and preventive actions, maintaining device master and history records, controlling nonconforming product, and validating critical processes, particularly for the 'Sympto-Therm' device. Additionally, the inspection noted an absence of management reviews, quality audit procedures, personnel training protocols, and controls for documents, product acceptance, storage, handling, and distribution, as well as equipment calibration. The company is required to promptly address these systemic failures by developing and implementing a comprehensive and compliant quality management system to ensure product safety and effectiveness.

## Related Documents

- [483 - 2023-03-24](https://www.keypedia.com/records/483/cydmax-india-pharma-private-limited/87b37d06-b1e1-47ba-af03-c20c25025106)
- [483 - 2025-04-25](https://www.keypedia.com/records/483/cydmax-india-pharma-private-limited/cabd7b5f-4079-44cb-8adf-65d7fb973598)
- [483 - 2025-04-25](https://www.keypedia.com/records/483/cydmax-india-pharma-private-limited/da2afb4a-4d71-4d70-a959-a036ad1aea4d)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/cydmax-india-pharma-private-limited/9b8090c9-5e3d-4bba-b398-0d3120d703f8

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