# Dishman Carbogen Amcis Limited – FDA 483, Mar 7, 2024

Source: https://www.keypedia.com/records/483/dishman-carbogen-amcis-limited/fcdeede5-bbb7-461f-8919-5a5b2da09f1a

> FDA 483 for Dishman Carbogen Amcis Limited on March 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dishman Carbogen Amcis Limited
- Inspection Date: 2024-03-07
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Dishman Carbogen Amcis Limited, an API manufacturer in Sanand (Bavla) Ahmedabad Gujarat, revealed four observations related to significant deficiencies in their manufacturing processes. The issues included inadequate equipment maintenance, incomplete batch records, insufficient GMP training for employees, and a lack of detailed procedures for the storage and handling of temperature-sensitive components. These findings indicate a need for improved procedural controls and documentation to ensure product quality and compliance.

## Related Documents

- [483 - 2018-10-26](https://www.keypedia.com/records/483/dishman-carbogen-amcis-limited/83a50ef2-f139-47ea-9554-3477e9ce8acc) — date: October 26, 2018

## Related Officers

- [Asher Parikh](https://www.keypedia.com/people/asher-parikh/2c5b4be1-e0d5-443f-a68a-d2fb2f0a7f36)

Company: https://www.keypedia.com/companies/dishman-carbogen-amcis-limited/939c244d-55e9-4adb-8df2-1add2fe18427

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3