# FDA 483 - Biological E. Limited - Unknown Date

Source: https://www.keypedia.com/records/483/biological-e-limited/4338a214-68c0-46ff-b4e8-2bcdb0f79bf7

> FDA 483 for Biological E. Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biological E. Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 report for Biological E. Limited in Medchal-Malkajgiri District, India, details significant deficiencies in aseptic processing, quality control, and laboratory procedures. The inspection revealed issues including inadequate corrective actions for media fill failures, insufficient microbiological contamination prevention, and lack of proper oversight by the quality control unit. These observations indicate a high severity of non-compliance with cGMP regulations, particularly concerning sterile drug product manufacturing.

## Related Documents

- [483 - 2021-10-08](https://www.keypedia.com/records/483/biological-e-limited/92999a80-cadd-4e7f-ab27-484d8dfad6f9)
- [483 - 2024-11-12](https://www.keypedia.com/records/483/biological-e-limited/60e7c678-9149-479b-98bb-dbe511d70b80)

## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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

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