Genzyme Corporation
FDA inspection history across 2 sites, 2001 to 2009
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2001: one warning letter; 2008: one Form 483; 2009: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001One warning letter, at Cambridge, Massachusetts.
- 2008–09Two Form 483s, at Allston, Massachusetts.
- 2009The longest 483 on file: 49 observations over 23 pages at Allston, Massachusetts.
Cited most
Across all Genzyme observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Genzyme file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Allston, Massachusetts
Two Form 483s · 2008 to 2009 · 65 observations
Latest: Form 483, Nov 13, 2009 →Cambridge, Massachusetts
One warning letter · 2001
Latest: Warning letter, Nov 8, 2001 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2009-11-13 | 483 Form 483 | Allston, Massachusetts | 49 | $99 |
| 2008-10-10 | 483 Form 483 | Allston, Massachusetts | 16 | $99 |
| 2001-11-08 | Warning letter Warning letter | Cambridge, Massachusetts | — | $99 |
Investigators on these documents
FEI number 1000305672 · most recent document Nov 13, 2009
About Genzyme Corporation
How many FDA Form 483s has Genzyme Corporation received?
FDA Intel has 2 Form 483s on file for Genzyme Corporation; the most recent is dated Nov 13, 2009.
When was Genzyme Corporation last inspected by FDA?
The most recent FDA inspection document on file for Genzyme Corporation is a Form 483 dated Nov 13, 2009, for the site in Allston, Massachusetts.
What did FDA cite at Genzyme Corporation?
The regulations cited most in the observations on file for Genzyme Corporation are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.
Has Genzyme Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Genzyme Corporation; the most recent is dated Nov 8, 2001.