Alkem Laboratories Ltd No. 8, Old National Highway at Naugama

FDA inspection history in Mandva, India, 2015

1
Form 483

Every document, by year

  • Form 483

2015: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One Form 483, at Mandva, India.

Cited most

Across all Alkem Laboratories Ltd No. 8, Old National Highway at Naugama observations on file

The complete Alkem Laboratories Ltd No. 8, Old National Highway at Naugama file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2015-09-18483 Form 483$99

Investigators on these documents

Tamil Arasu (1)

FEI number 3008450172 · most recent document Sep 18, 2015

About Alkem Laboratories Ltd No. 8, Old National Highway at Naugama

How many FDA Form 483s has Alkem Laboratories Ltd No. 8, Old National Highway at Naugama received?

FDA Intel has 1 Form 483 on file for Alkem Laboratories Ltd No. 8, Old National Highway at Naugama; the most recent is dated Sep 18, 2015.

When was Alkem Laboratories Ltd No. 8, Old National Highway at Naugama last inspected by FDA?

The most recent FDA inspection document on file for Alkem Laboratories Ltd No. 8, Old National Highway at Naugama is a Form 483 dated Sep 18, 2015, for the site in Mandva, India.

What did FDA cite at Alkem Laboratories Ltd No. 8, Old National Highway at Naugama?

The regulations cited most in the observations on file for Alkem Laboratories Ltd No. 8, Old National Highway at Naugama are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.