EMD Serono, Inc
Form 483 issued June 17, 2016 · Rockland, Massachusetts
- Inspection
- May 26 – Jun 17, 2016
- Investigators
- Erik W. Koester· John P. Mistler
- Observations
- 1
- Pages
- 5
- FEI number
- 1220970
In short: On June 17, 2016, FDA issued a Form 483 with 1 observation to EMD Serono, Inc in Rockland, Massachusetts (FEI 1220970) after an inspection that ran May 26 – Jun 17, 2016. The investigators were Erik W. Koester and John P. Mistler. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmEMD Serono, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EMD Serono, Inc?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected EMD Serono, Inc?
Erik W. Koester and John P. Mistler are named on this Form 483, for the inspection of May 26 – Jun 17, 2016. Each investigator has a profile showing what they cite most.
When was EMD Serono, Inc inspected by FDA?
The inspection ran May 26 – Jun 17, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for EMD Serono, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.