> ## 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.

# 5 Repeat CGMP Violations at Indoco Remedies
- URL: https://www.fdaweb.com/5-repeat-cgmp-violations-at-indoco-remedies/
- Published: 2025-01-07T12:00:00.000Z
- Updated: 2026-09-14T14:50:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158433

A 7/16-7/26/2024 FDA inspection at the Indoco Remedies drug manufacturing facility in Goa, India, found repeat significant violations of current good manufacturing practice (CGMP) regulations. A just-released 12/16/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024?ref=fdaweb.com) says the specific violations were:

- failure to record and justify any deviations from required laboratory control mechanisms;
- failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failure to establish an adequate system for maintaining equipment used to control the aseptic conditions;
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failure to establish an adequate quality unit and to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

The letter says the agency cited similar violations in a 2023 inspection and that Indoco proposed specific remediations for the violations in its response. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says.

FDA also says that Indoco does not operate an effective quality system following CGMPs and recommends the firm retain a qualified consultant to assist it in meeting CGMP requirements.

The firm was told to correct violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.