AMOL PHARMACEUTICALS PRIVATE LIMITED

FDA inspection history in Jaipur, India, 2018 to 2019

2
Form 483s

Every document, by year

  • Form 483

2018: one Form 483; 2019: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018–19Two Form 483s, at Jaipur, India.
  2. 2018The longest 483 on file: 11 observations over 19 pages at Jaipur, India.

Cited most

Across all AMOL PHARMACEUTICALS PRIVATE LIMITED observations on file

The complete AMOL PHARMACEUTICALS 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
2019-09-13483 Form 483$99
2018-02-16483 Form 483$99

Investigators on these documents

Pratik S. Upadhyay (1)Unnee Ranjan (1)

FEI number 3003925108 · most recent document Sep 13, 2019

About AMOL PHARMACEUTICALS PRIVATE LIMITED

How many FDA Form 483s has AMOL PHARMACEUTICALS PRIVATE LIMITED received?

FDA Intel has 2 Form 483s on file for AMOL PHARMACEUTICALS PRIVATE LIMITED; the most recent is dated Sep 13, 2019.

When was AMOL PHARMACEUTICALS PRIVATE LIMITED last inspected by FDA?

The most recent FDA inspection document on file for AMOL PHARMACEUTICALS PRIVATE LIMITED is a Form 483 dated Sep 13, 2019, for the site in Jaipur, India.

What did FDA cite at AMOL PHARMACEUTICALS PRIVATE LIMITED?

The regulations cited most in the observations on file for AMOL PHARMACEUTICALS PRIVATE LIMITED are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.186(a) (Master production and control records), 2 times; 21 CFR 11, 1 time.