# FDA 483 - Recipharm Pharmaservices Private Limited - February 13, 2020

Source: https://www.globalkeysolutions.net/records/483/recipharm-pharmaservices-private-limited/526cedaa-2184-4035-ba1a-74360cb81877

> FDA 483 for Recipharm Pharmaservices Private Limited on February 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Recipharm Pharmaservices Private Limited
- Inspection Date: 2020-02-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Recipharm Pharmaservices Private Limited, a drug manufacturer in Bangalore, Karnataka, India, revealed significant deficiencies in equipment management and electronic recordkeeping. The firm failed to perform routine inspections of automatic, mechanical, and electronic equipment according to a written program, and electronic records lacked proper retention, system access limitations, and audit trails. These issues compromise the trustworthiness and reliability of critical data, indicating serious quality control and data integrity concerns.

## Related Documents

- [483 - 2019-02-01](https://www.globalkeysolutions.net/records/483/recipharm-pharmaservices-private-limited/1feb07d0-7f4e-4d1f-84ed-d09c3c08c0c4)

## Related Officers

- [Jason R. Caballero](https://www.globalkeysolutions.net/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.globalkeysolutions.net/companies/recipharm-pharmaservices-private-limited/cb3eebaa-2270-4301-a4a2-3ce95d076cd6

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