New England Compounding Center
FDA inspection history in Framingham, Massachusetts, 2002 to 2012
- 4
- Form 483s
- 3
- Responses
- 2
- EIRs
Every document, by year
- Form 483
- Response
- EIR
2002: one inspection report and one Form 483; 2003: two 483 responses, one inspection report and one Form 483; 2007: one warning letter response; 2008: one fda_correspondence; 2012: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2002–03Two inspection reports, two Form 483s and two 483 responses, at Framingham, Massachusetts.
- 2007–08One warning letter response and one fda_correspondence, at Framingham, Massachusetts.
- 2012Two Form 483s, at Framingham, Massachusetts.
- 2012The longest 483 on file: 5 observations over 8 pages at Framingham, Massachusetts.
Cited most
Across all New England Compounding Center observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.198Complaint files2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160General requirements1
- 21 CFR 211.167Special testing requirements1
The complete New England Compounding Center file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Framingham, Massachusetts
Four Form 483s, two 483 responses, two inspection reports, one fda_correspondence and one warning letter response · 2002 to 2012 · 17 observations
Latest: Form 483, Nov 1, 2012 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-11-01 | 483 Form 483 | Framingham, Massachusetts | 5 | $99 |
| 2012-10-26 | 483 Form 483 | Framingham, Massachusetts | 5 | $99 |
| 2008-10-31 | fda_correspondence FDA document | Framingham, Massachusetts | — | — |
| 2007-01-05 | Response Warning letter response | Framingham, Massachusetts | — | $199 |
| 2003-05-16 | Response 483 response | Framingham, Massachusetts | — | $199 |
| 2003-02-26 | Response 483 response | Framingham, Massachusetts | — | $199 |
| 2003-02-10 | EIR EIR | Framingham, Massachusetts | — | $550 |
| 2003-02-10 | 483 Form 483 | Framingham, Massachusetts | 3 | $99 |
| 2002-04-16 | EIR EIR | Framingham, Massachusetts | — | $550 |
| 2002-04-16 | 483 Form 483 | Framingham, Massachusetts | 4 | $99 |
Investigators on these documents
Kristina M. Joyce (5)Daryl A. Dewoskin (3)Mark Lookabaugh (2)Philip Kreiter (2)Karen M. Risi (1)Stacey S. Degarmo (1)Almaris N. Alonso (1)Thomas W. Nemey (1)Constance Desimone (1)David J. Pels (1)Debra M. Emerson (1)
FEI number 3003623877 · most recent document Nov 1, 2012
About New England Compounding Center
How many FDA Form 483s has New England Compounding Center received?
FDA Intel has 4 Form 483s on file for New England Compounding Center; the most recent is dated Nov 1, 2012.
When was New England Compounding Center last inspected by FDA?
The most recent FDA inspection document on file for New England Compounding Center is a Form 483 dated Nov 1, 2012, for the site in Framingham, Massachusetts.
What did FDA cite at New England Compounding Center?
The regulations cited most in the observations on file for New England Compounding Center are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.