Janssen Biotech, Inc.

FDA inspection history in Malvern, Pennsylvania, 2018

1
Form 483

Every document, by year

  • Form 483

2018: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018One Form 483, at Malvern, Pennsylvania.

Cited most

Across all Janssen Biotech observations on file

The complete Janssen Biotech 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

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Documents

1 on file, newest first
DateDocumentPrice
2018-03-05483 Form 483$99

Investigators on these documents

Anita R. Michael (1)

FEI number 3001610451 · most recent document Mar 5, 2018

About Janssen Biotech, Inc.

How many FDA Form 483s has Janssen Biotech, Inc. received?

FDA Intel has 1 Form 483 on file for Janssen Biotech, Inc.; the most recent is dated Mar 5, 2018.

When was Janssen Biotech, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Janssen Biotech, Inc. is a Form 483 dated Mar 5, 2018, for the site in Malvern, Pennsylvania.

What did FDA cite at Janssen Biotech, Inc.?

The regulations cited most in the observations on file for Janssen Biotech, Inc. are 21 CFR 211.192 (Production record review), 1 time.