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# API Deviations in Vipor Chemicals Inspection
- URL: https://www.fdaweb.com/api-deviations-in-vipor-chemicals-inspection/
- Published: 2019-02-20T12:00:00.000Z
- Updated: 2026-09-15T01:06:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143421

A 2/21-2/24/18 FDA inspection at the Vipor Chemicals drug manufacturing facility in Vadodara, Gujarat, India, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients. A just-released 1/29 Warning Letter says the specific deviations were: 

- failing to transfer all quality or regulatory information received from the API manufacturer to Vipor’s customers;
- failing to have the procedures and processes necessary to ensure the API manufactured in Vipor’s facility meet established specifications for quality and purity;
- failing to establish and follow adequate written procedures for cleaning equipment and its release for use in the manufacture of API; and
- failing to demonstrate that the water used in the manufacture of Vipor’s API is suitable for its intended use.

Based on the nature of the deviations found at the inspection, FDA recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. Vipor was placed on an import alert 7/11/18.

The company was told to respond with a list of specific actions taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.