EMD Serono, Inc

FDA inspection history in Rockland, Massachusetts, 2016

1
Form 483

Every document, by year

  • Form 483

2016: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2016One Form 483, at Rockland, Massachusetts.

Cited most

Across all EMD Serono observations on file

The complete EMD Serono 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
2016-06-17483 Form 483$99

Investigators on these documents

Erik W. Koester (1)John P. Mistler (1)

FEI number 1220970 · most recent document Jun 17, 2016

About EMD Serono, Inc

How many FDA Form 483s has EMD Serono, Inc received?

FDA Intel has 1 Form 483 on file for EMD Serono, Inc; the most recent is dated Jun 17, 2016.

When was EMD Serono, Inc last inspected by FDA?

The most recent FDA inspection document on file for EMD Serono, Inc is a Form 483 dated Jun 17, 2016, for the site in Rockland, Massachusetts.

What did FDA cite at EMD Serono, Inc?

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