Sun Pharmaceutical Ltd

FDA inspection history across 2 sites, 2015 to 2020

2
Form 483s

Every document, by year

  • Form 483

2015: one Form 483; 2020: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One Form 483, at Maharashtra, India.
  2. 2015The longest 483 on file: 2 observations over 2 pages at Maharashtra, India.
  3. 2020One Form 483, at Ahilyanagar, India.

Cited most

Across all Sun Pharmaceutical observations on file

The complete Sun Pharmaceutical 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

Documents

2 on file, newest first
DateDocumentPrice
2020-01-24483 Form 483$99
2015-06-19483 Form 483$99

Investigators on these documents

Dinesh Shah (1)Nadeem I. Chaudhry (1)

FEI number 3003227153 · most recent document Jan 24, 2020

About Sun Pharmaceutical Ltd

How many FDA Form 483s has Sun Pharmaceutical Ltd received?

FDA Intel has 2 Form 483s on file for Sun Pharmaceutical Ltd; the most recent is dated Jan 24, 2020.

When was Sun Pharmaceutical Ltd last inspected by FDA?

The most recent FDA inspection document on file for Sun Pharmaceutical Ltd is a Form 483 dated Jan 24, 2020, for the site in Ahilyanagar, India.

What did FDA cite at Sun Pharmaceutical Ltd?

The regulations cited most in the observations on file for Sun Pharmaceutical Ltd are 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time; 21 CFR 211.80 (General requirements), 1 time.