# FDA 483 - Arene Life Sciences Private Limited - August 30, 2024

Source: https://www.keypedia.com/records/483/arene-life-sciences-private-limited/ef6f410d-2f17-489a-8f7c-707e0060b16e

> FDA 483 for Arene Life Sciences Private Limited on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arene Life Sciences Private Limited
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Arene Life Sciences Limited, an API manufacturer in Sangareddy, India, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the proper performance and assessment of electronic equipment, specifically regarding power supply disruptions and their impact on data integrity. Additionally, the firm failed to contemporaneously record laboratory data, indicating issues with laboratory control mechanisms and documentation practices.

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/arene-life-sciences-private-limited/c0fef3d1-c540-4779-95d2-c2243a0a7185

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