# FDA 483 - Biological E. Limited - October 08, 2021

Source: https://www.globalkeysolutions.net/records/483/biological-e-limited/92999a80-cadd-4e7f-ab27-484d8dfad6f9

> FDA 483 for Biological E. Limited on October 08, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biological E. Limited
- Inspection Date: 2021-10-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biological E. Limited in Hyderabad, India, an API and finished drug manufacturer, received a Form 483 with six observations primarily concerning significant deficiencies in quality control, data integrity, and equipment management. Issues included failures to investigate discrepancies, inadequate computer system controls, poor equipment cleaning, and non-adherence to stability testing and quality unit procedures. These findings indicate a systemic lack of adherence to cGMP requirements, posing risks to drug product quality and purity.

## Related Documents

- [483 - 2024-11-12](https://www.globalkeysolutions.net/records/483/biological-e-limited/60e7c678-9149-479b-98bb-dbe511d70b80)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/biological-e-limited/4338a214-68c0-46ff-b4e8-2bcdb0f79bf7)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/biological-e-limited/a02640a2-3dc0-448e-9a4f-df7e189939e4

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