# SHIMOGA CHEMICALS – FDA 483, Jan 23, 2026

Source: https://www.keypedia.com/records/483/shimoga-chemicals/c26f620d-dbe3-4645-b1a3-d923009ce5c9

> FDA 483 for SHIMOGA CHEMICALS on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SHIMOGA CHEMICALS
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Shimoga Chemicals, an API manufacturer in Sangli, India, was cited for numerous severe deficiencies during an FDA inspection. The findings highlight systemic data integrity issues in laboratory controls and batch records, inadequate process validation, poor equipment cleaning and maintenance, insufficient stability data, and a complete lack of thorough investigations into discrepancies and OOS results. These observations indicate a significant failure to adhere to cGMP requirements across multiple critical areas of drug manufacturing.

## Related Documents

- [WARNING_LETTER - 2026-01-23](https://www.keypedia.com/records/warning_letter/shimoga-chemicals/f2946eb5-f51e-4737-a781-cf0d4d6556d6) — date: January 23, 2026

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Rachael A. Moss](https://www.keypedia.com/people/rachael-a-moss/520fef7c-dc4b-47af-9c52-3718ab3fb612)

Company: https://www.keypedia.com/companies/shimoga-chemicals/0330188b-23be-4404-8a00-7d91016510f4

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8