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# Multiple Violations at Kilitch Healthcare India
- URL: https://www.fdaweb.com/multiple-violations-at-kilitch-healthcare-india/
- Published: 2024-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:27:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156733

A 10/12-10/20/2023 FDA inspection at the Kilitch Healthcare India drug manufacturing facility in Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/28 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kilitch-healthcare-india-limited-672956-03282024?ref=fdaweb.com) says the firm’s drugs were adulterated because they were prepared, packed, or held under insanitary conditions and did not conform with CGMP regulations. “FDA investigators observed your facility to be in a state of disrepair \[and\] poorly cleaned and maintained,” the letter says.

Specific CGMP violations were:

- 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 ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas; and
- failure of the quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP,” FDA says. “In addition to the lack of effective management oversight, your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”

The agency notes it recommended on 10/25/2023 that Kilitch recall all sterile ophthalmic drug products within expiry due to the insanitary conditions at the facility, but it took until 11/15/2023 for Kilitch to issue a recall.

The letter acknowledges the firm’s commitment to suspend production of all drugs for the U.S. market and asks that it notify FDA if it plans to resume manufacturing operations.

FDA recommends that Kilitch retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market.

Kilitch was placed on an FDA Import Alert on 10/23/2023\. The company was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.