Tyche Industries Limited
Form 483 issued August 16, 2024 · KAKINADA, India
- Inspection
- Aug 12 – Aug 16, 2024
- Investigator
- Nibin Varghese
- Observations
- 2
- Pages
- 7
- FEI number
- 3004790309
In short: On August 16, 2024, FDA issued a Form 483 with 2 observations to Tyche Industries Limited in KAKINADA, Andhra Pradesh (FEI 3004790309) after an inspection that ran Aug 12 – Aug 16, 2024. The investigator was Nibin Varghese. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured…
- 02
Failure of your quality unit to ensure that quality-related complaints…
This inspection in context
Nibin Varghese
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmTyche Industries Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tyche Industries Limited?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Tyche Industries Limited?
Nibin Varghese is named on this Form 483, for the inspection of Aug 12 – Aug 16, 2024. Each investigator has a profile showing what they cite most.
When was Tyche Industries Limited inspected by FDA?
The inspection ran Aug 12 – Aug 16, 2024, and the Form 483 is dated August 16, 2024.
How do I get the full Form 483 for Tyche Industries Limited?
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.