Garonit Pharmaceutical, Inc.

FDA inspection history in Fairfield, New Jersey, 2020 to 2023

2
Form 483s

Every document, by year

  • Form 483

2020: one Form 483; 2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2020One Form 483, at Fairfield, New Jersey.
  2. 2023One Form 483, at Fairfield, New Jersey.
  3. 2023The longest 483 on file: 2 observations over 3 pages at Fairfield, New Jersey.

Cited most

Across all Garonit Pharmaceutical observations on file

The complete Garonit 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
2023-07-06483 Form 483$99
2020-01-14483 Form 483$99

Investigators on these documents

Janet A. Rajan (1)

FEI number 3003961853 · most recent document Jul 6, 2023

About Garonit Pharmaceutical, Inc.

How many FDA Form 483s has Garonit Pharmaceutical, Inc. received?

FDA Intel has 2 Form 483s on file for Garonit Pharmaceutical, Inc.; the most recent is dated Jul 6, 2023.

When was Garonit Pharmaceutical, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Garonit Pharmaceutical, Inc. is a Form 483 dated Jul 6, 2023, for the site in Fairfield, New Jersey.

What did FDA cite at Garonit Pharmaceutical, Inc.?

The regulations cited most in the observations on file for Garonit Pharmaceutical, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.