Genzyme Corporation
Form 483 issued October 10, 2008 · Allston, Massachusetts
- Inspection
- Sep 15 – Oct 10, 2008
- Investigator
- Debra M. Emerson
- Observations
- 16
- Pages
- 6
- FEI number
- 1000305672
In short: On October 10, 2008, FDA issued a Form 483 with 16 observations to Genzyme Corporation in Allston, Massachusetts (FEI 1000305672) after an inspection that ran Sep 15 – Oct 10, 2008. The investigator was Debra M. Emerson. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 9 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Activities performed during,~,r\lg product manufacture are not documented. For example: a. Myozyme~ was filled into vials…
- 02
5.Activities are performed during drug substance manufacture that are…
- 03
Observation 3: scanned text, readable in the full document.
- 04
7. The aseptic filling of all drug products into vials at…
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genzyme Corporation?
FDA listed 16 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Genzyme Corporation?
Debra M. Emerson is named on this Form 483, for the inspection of Sep 15 – Oct 10, 2008. Each investigator has a profile showing what they cite most.
When was Genzyme Corporation inspected by FDA?
The inspection ran Sep 15 – Oct 10, 2008, and the Form 483 is dated October 10, 2008.
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.