# FDA 483 - Alembic Pharmaceuticals Limited - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/alembic-pharmaceuticals-limited/97ef6ddd-e6f2-48cd-b33f-a81d19df3d58

> FDA 483 for Alembic Pharmaceuticals Limited on November 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Inspection Date: 2024-11-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Alembic Pharmaceuticals Limited in Jarod, India, received a Form 483 with five observations during an FDA inspection. The findings highlight significant deficiencies in manufacturing process control, including inadequate identification of critical process parameters and statistical evaluations. Additionally, issues were noted in quality control sampling, equipment cleaning procedures, analytical method validation, and data integrity within computer systems.

## Related Documents

- [483 - 2022-12-16](https://www.globalkeysolutions.net/records/483/alembic-pharmaceuticals-limited/4a94c328-8b9f-47b5-b129-9d9a0c6f27e8)

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.globalkeysolutions.net/companies/alembic-pharmaceuticals-limited/312ff75c-8a88-40fe-a7a6-52fa52c791cb

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8