Tyche Industries Limited

FDA inspection history across 2 sites, 2024 to 2025

1
Warning letter: 1
Form 483

Every document, by year

Warning letter
Form 483

The story so far

Built from the dates and citations on the documents themselves.

2024–25One Form 483 and one warning letter, at KAKINADA, India and Kakinada, India.

Cited most

Across all Tyche Industries Limited observations on file

21 CFR 211.198
Complaint files
1
21 CFR 211.22
Responsibilities of quality control unit
1

The complete Tyche Industries Limited file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Kakinada, India
One warning letter · 2025
Latest: Warning letter, Feb 6, 2025 →
KAKINADA, India
One Form 483 · 2024 · 2 observations
Latest: Form 483, Aug 16, 2024 →

Documents

2 on file, newest first

Date	Document	Location	Observations	Price
2025-02-06	Warning letter Warning letter	Kakinada, India	—	$99
2024-08-16	483 Form 483	KAKINADA, India	2	$99

Investigators on these documents

Nibin Varghese (1)

FEI number 3004790309 · most recent document Feb 6, 2025

About Tyche Industries Limited

How many FDA Form 483s has Tyche Industries Limited received?

FDA Intel has 1 Form 483 on file for Tyche Industries Limited; the most recent is dated Aug 16, 2024.

When was Tyche Industries Limited last inspected by FDA?

The most recent FDA inspection document on file for Tyche Industries Limited is a Form 483 dated Aug 16, 2024, for the site in KAKINADA, India.

What did FDA cite at Tyche Industries Limited?

The regulations cited most in the observations on file for Tyche Industries Limited are 21 CFR 211.198 (Complaint files), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.

Has Tyche Industries Limited received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Tyche Industries Limited; the most recent is dated Feb 6, 2025.