# FDA 483 - Recipharm Pharmaservices Private Limited - February 01, 2019

Source: https://www.globalkeysolutions.net/records/483/recipharm-pharmaservices-private-limited/1feb07d0-7f4e-4d1f-84ed-d09c3c08c0c4

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

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## Details

- Record Type: 483
- Company Name: Recipharm Pharmaservices Private Limited
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Recipharm Pharmaservices Private Limited in Bangalore, India, received a Form 483 with three observations during an inspection from January 28 to February 1, 2019. The observations primarily concern inadequate equipment qualification and control, insufficient process control procedures including data integrity issues, and failures in following gowning and sanitation procedures to prevent contamination in drug product manufacturing areas. These issues indicate significant deficiencies in the firm's quality systems and manufacturing controls.

## Related Documents

- [483 - 2020-02-13](https://www.globalkeysolutions.net/records/483/recipharm-pharmaservices-private-limited/526cedaa-2184-4035-ba1a-74360cb81877)

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.globalkeysolutions.net/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

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