Genzyme Corporation
Form 483 issued November 13, 2009 · Allston, Massachusetts
- Inspection
- Oct 8 – Nov 13, 2009
- Investigators
- Debra M. Emerson· Thomas J. Arista
- Observations
- 49
- Pages
- 23
- FEI number
- 1000305672
In short: On November 13, 2009, FDA issued a Form 483 with 49 observations to Genzyme Corporation in Allston, Massachusetts (FEI 1000305672) after an inspection that ran Oct 8 – Nov 13, 2009. The investigators were Debra M. Emerson and Thomas J. Arista. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Vice President of Quality Operations US Therapeutics confirms there is no established standard operating procedure…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Control procedures are not established which monitor the output or validate the performance of those manufacturing…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmGenzyme Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Genzyme Corporation?
FDA listed 49 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Genzyme Corporation?
Debra M. Emerson and Thomas J. Arista are named on this Form 483, for the inspection of Oct 8 – Nov 13, 2009. Each investigator has a profile showing what they cite most.
When was Genzyme Corporation inspected by FDA?
The inspection ran Oct 8 – Nov 13, 2009, and the Form 483 is dated November 13, 2009.
How do I get the full Form 483 for Genzyme Corporation?
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.