> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Deviations at Indiana Chem-Port
- URL: https://www.fdaweb.com/cgmp-deviations-at-indiana-chem-port/
- Published: 2022-02-15T12:00:00.000Z
- Updated: 2026-09-14T17:32:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151158

An 8/2-8/7/21 FDA inspection at Indiana Chem-Port, Vadodara Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A 2/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indiana-chem-port-618173-02022022?ref=fdaweb.com) says the deviations were: 

- failing to ensure that equipment surfaces in contact with APIs do not alter the quality of the APIs beyond the official or other established specifications;
- failing to demonstrate that the manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes;
- failing to adequately validate written procedures for the cleaning and maintenance of equipment and failing to establish adequate written procedures for cleaning equipment and its release for use in manufacturing APIs;
- failing to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm appropriate storage conditions and retest or expiry dates; and
- failing to have a quality unit that is independent of production and fulfills quality assurance and quality control duties.

The letter also says Indiana Chem-Port has not fulfilled its registration requirement as an API manufacturer and has not properly listed with FDA the drug it manufactures for commercial distribution in the U.S.

FDA recommends that the firm retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The firm was placed on a 12/13/21 import alert.

Indiana Chem-Port was told to correct any deviations promptly and to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.