Shimoga Chemicals
Form 483 issued January 23, 2026
- Inspection
- Jan 19 – Jan 23, 2026
- Observations
- 10
- Pages
- 14
- FEI number
- 3033881432
In short: On January 23, 2026, FDA issued a Form 483 with 10 observations to Shimoga Chemicals (FEI 3033881432) after an inspection that ran Jan 19 – Jan 23, 2026.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Procedures for the cleaning and maintenance of equipment and its release for use in the manufacture…
This inspection in context
Questions about this 483
What did FDA find at Shimoga Chemicals?
FDA listed 10 observations on this Form 483. The opening words of each observation are shown on this page.
When was Shimoga Chemicals inspected by FDA?
The inspection ran Jan 19 – Jan 23, 2026, and the Form 483 is dated January 23, 2026.
How do I get the full Form 483 for Shimoga Chemicals?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.