Steril-Gene Life Sciences Private Limited

FDA inspection history in Puducherry, India, 2019 to 2022

2
Form 483s

Every document, by year

  • Form 483

2019: one Form 483; 2022: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2019One Form 483, at Puducherry, India.
  2. 2019The longest 483 on file: 2 observations over 3 pages at Puducherry, India.
  3. 2022One Form 483, at Puducherry, India.

Cited most

Across all Steril-Gene Life Sciences Private Limited observations on file

The complete Steril-Gene Life Sciences Private 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

Documents

2 on file, newest first
DateDocumentPrice
2022-11-25483 Form 483$99
2019-12-10483 Form 483$99

Investigators on these documents

Dennis Cantellops (1)Jose Velez (1)

FEI number 3014319211 · most recent document Nov 25, 2022

About Steril-Gene Life Sciences Private Limited

How many FDA Form 483s has Steril-Gene Life Sciences Private Limited received?

FDA Intel has 2 Form 483s on file for Steril-Gene Life Sciences Private Limited; the most recent is dated Nov 25, 2022.

When was Steril-Gene Life Sciences Private Limited last inspected by FDA?

The most recent FDA inspection document on file for Steril-Gene Life Sciences Private Limited is a Form 483 dated Nov 25, 2022, for the site in Puducherry, India.

What did FDA cite at Steril-Gene Life Sciences Private Limited?

The regulations cited most in the observations on file for Steril-Gene Life Sciences Private Limited are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.67(b)(6) (Equipment cleaning and maintenance), 1 time.