# FDA 483 - Alembic Pharmaceuticals Limited (Units I and II) - May 31, 2025

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited-units-i-and-ii/f200c308-1b31-4876-9642-bc0c3f9c2920

> FDA 483 for Alembic Pharmaceuticals Limited (Units I and II) on May 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited (Units I and II)
- Inspection Date: 2025-05-31
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an FDA inspection conducted from May 26-31, 2025, Alembic Pharmaceuticals Limited (Units I and II), an API manufacturer in Gujarat, India, received a Form FDA 483 listing four significant observations regarding its quality and control systems. Key issues included a deficient Quality System, where laboratory investigations for "Out of Trend" and "Out of Specification" stability results for active pharmaceutical ingredients were not timely or thoroughly conducted. Root cause analyses were found inadequate, and discrepancies in test results lacked proper justification. The Laboratory Control System was also cited for using analytical test procedures that were not adequately validated as stability-indicating, with many methods failing to demonstrate sufficient degradation under stress conditions. Furthermore, the Facility and Equipment System revealed non-dedicated production equipment in disrepair and containing residual powdery materials while tagged "Ready for use," indicating insufficient cleaning and maintenance that could lead to contamination. Examples included various processing equipment with residues, peeled coatings, dents, and corrosion. Lastly, there was a critical lack of Quality Unit oversight on document control, as employees were found using uncontrolled papers for documenting critical GMP activities, bypassing formal record-keeping and incident logging procedures. These observations highlight deviations from Current Good Manufacturing Practice (CGMP) regulations. Alembic Pharmaceuticals is required to provide a comprehensive response detailing corrective and preventive actions to address these deficiencies.

## Related Documents

- [483 - 2025-05-31](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited-units-i-and-ii/d93249a3-40b4-4a57-b7b3-726eaec789cf)
- [483 - 2025-05-26](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited-units-i-and-ii/572804fe-e82a-4cba-8325-58bdcf2ed319)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [company_representative](https://www.keypedia.com/people/pradeep-chakravarty/ce40b2f5-9552-4b72-9df3-cde3be0504b2)

Company: https://www.keypedia.com/companies/alembic-pharmaceuticals-limited-units-i-and-ii/68fd4724-f974-4ddc-8882-a5d28dc90916

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa