> ## 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 Violation at India’s Chemspec Chemicals
- URL: https://www.fdaweb.com/cgmp-violation-at-indias-chemspec-chemicals/
- Published: 2026-01-13T12:00:00.000Z
- Updated: 2026-09-14T15:30:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160475

A 7/28-8/1/2025 FDA inspection at the Chemspec Chemicals Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India, found a significant deviation from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 12/23/2025 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chemspec-chemicals-private-limited-718403-12232025?ref=fdaweb.com) says the specific deviation was a failure of the firm’s quality control unit to exercise its responsibility to ensure the APIs and intermediates manufactured at the facility comply with CGMP.

The letter says the firm’s response to the inspection observation was inadequate. The agency notes that the Chemspec quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It strongly recommends that the company engage a qualified consultant to assist in its remediation.

FDA says a 2/5/2025 untitled letter referenced a similar deviation, and the company proposed remediations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of APIs are inadequate,” it says.

Chemspec was told to respond with a list of specific actions it has taken to address the deficiencies and prevent their recurrence, with a schedule for completing the corrections.