# FDA 483 - Rxhomeo Private Limited - February 01, 2019

Source: https://www.keypedia.com/records/483/rxhomeo-private-limited/5de003b0-9d94-49af-8223-b72482805e08

> FDA 483 for Rxhomeo Private Limited on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rxhomeo Private Limited
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Rxhomeo Private Limited, a homeopathic drug manufacturer in Hyderabad, Telangana, India, revealed significant deficiencies across its quality system. The firm lacks numerous essential written procedures for production, process controls, equipment management, and quality control. Additionally, batch production records are incomplete, and there are failures in component release, labeling controls, product specifications, instrument calibration, and stability assessments.

## Related Documents

- [WARNING_LETTER - 2019-02-01](https://www.keypedia.com/records/warning_letter/rxhomeo-private-limited/c6b53b46-3b69-460c-9d56-423a030ec1a3)
- [483 - 2023-05-15](https://www.keypedia.com/records/483/rxhomeo-private-limited/8f53b1c8-8002-4b0b-aa68-31f6653e1a81)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/nadeem-i-chaudhry/7d867939-2dc6-4503-b9b9-6f26b16c347e)

Company: https://www.keypedia.com/companies/rxhomeo-private-limited/b62358de-da81-47bc-b931-127955ac12cb

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1