BIOCON GENERICS INC

FDA inspection history in Cranbury, New Jersey, 2020 to 2022

2
Form 483s

Every document, by year

  • Form 483

2020: one Form 483; 2022: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2020–22Two Form 483s, at Cranbury, New Jersey.
  2. 2022The longest 483 on file: 3 observations over 5 pages at Cranbury, New Jersey.

Cited most

Across all BIOCON GENERICS observations on file

The complete BIOCON GENERICS 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
2022-02-02483 Form 483$99
2020-09-08483 Form 483$99

Investigators on these documents

Annet R. Rajan (1)Yvins Dezan (1)

FEI number 3014086465 · most recent document Feb 2, 2022

About BIOCON GENERICS INC

How many FDA Form 483s has BIOCON GENERICS INC received?

FDA Intel has 2 Form 483s on file for BIOCON GENERICS INC; the most recent is dated Feb 2, 2022.

When was BIOCON GENERICS INC last inspected by FDA?

The most recent FDA inspection document on file for BIOCON GENERICS INC is a Form 483 dated Feb 2, 2022, for the site in Cranbury, New Jersey.

What did FDA cite at BIOCON GENERICS INC?

The regulations cited most in the observations on file for BIOCON GENERICS INC are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.