FDA Warning Letter for an Indian API Manufacturer

Background

The FDA inspected Shimoga Chemicals in Sangli, Maharashtra, India, in January 2026. The Warning Letter describes significant deviations from CGMP requirements for active pharmaceutical ingredients (APIs), including inadequate methods, facilities, and controls. The deficiencies particularly affect USP clomiphene citrate intended for the U.S. market.

Key Findings (Main Areas of Concern)

Data Integrity (highly critical):

• Multiple HPLC injections were not documented (related substances and assay). For example, Batch CC/005/24-25 included an unreported injection that produced an OOS result; instead, a compliant result appeared in the batch record.
• Procedures for the electronic review of data were lacking, and the Quality Unit did not review the electronic raw data. Nevertheless, the batch was released and shipped to the United States.

Sampling & In Process Controls:

• Batch records contained unclear or missing sampling instructions regarding the quantity, location, method, and timing of sampling.
• According to reports, samples were taken arbitrarily; in-process tests were not conducted systematically.

Method Verification/Validation:

• No method validation for relevant test methods (including identity, assay, related substances, and residual solvents).
• External/contract lab methods were also not verified.

Processvalidation:

• The validation reports do not accurately reflect actual practice (key process steps are missing).
• Hold times were not defined or supported by studies; some intermediate products were stored longer than was justified.

Cleaning (of equipment without clear assignment):

• Cleaning acceptance criteria were unclear and insufficiently justified.
• SOPs were not specific enough (methods, materials, contact times, verification).
• The practical cleaning procedure (“water only”) was inconsistent with the written guidelines.
• Risk: Cross-contamination between batches.

Investigations/OOS System:

• For years, virtually no OOS/OOT investigations were documented, despite the occurrence of such events, including the unreported OOS result.

Stability Program:

• Missing/incomplete raw data to support the assigned runtime.
• The company’s own requirement—placing at least one commercial batch on stability each year—was not followed (including no U.S. batches in 2025/2026).
• Stability samples were stored in non-equivalent packaging (not evaluated).

Training:

• Individuals performed critical activities even though there was no documented CGMP or functional qualification.

The FDA considers the company's response to date to be insufficient, in part because it lacks a thorough analysis of the OOS issue and a retest strategy using verified methods.

Expected Reaction and Consequences

The FDA requires comprehensive, partially independent assessments (laboratory, in-process/sampling, quality assurance, stability) with specific remediation plans and proof of effectiveness.  It also requires retrospective evaluations of invalidated out-of-specification (OOS) cases (including an investigation of possible manufacturing causes), as well as a robust process validation/PPQ program and risk-based cleaning validation based on the worst-case principle.
On May 14, 2026, a voluntary recall of clomiphene citrate USP took place. Furthermore, the company’s products were placed on Import Alert 66 40. The company must submit a written report within 15 business days detailing which corrective and preventive actions have been implemented or are planned, including a timeline.

For more details you will find the complete Warning Letter on the FDA-Website.