Ameridose, LLC
FDA inspection history across 2 sites, 2007 to 2012
- 4
- EIRs
- 2
- Form 483s
Every document, by year
- Form 483
- EIR
2007: one inspection report; 2008: two inspection reports and one Form 483; 2010: one inspection report; 2012: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2007–12Four inspection reports and two Form 483s, at Framingham, Massachusetts and Westborough, Massachusetts.
- 2012The longest 483 on file: 15 observations over 20 pages at Westborough, Massachusetts.
Cited most
Across all Ameridose observations on file
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.198Complaint files2
The complete Ameridose file.
All 6 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 inspection reports and one Form 483 · 2007 to 2010 · 6 observations
Latest: EIR, Jul 8, 2010 →Westborough, Massachusetts
One Form 483 · 2012 · 15 observations
Latest: Form 483, Nov 9, 2012 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-11-09 | 483 Form 483 | Westborough, Massachusetts | 15 | $99 |
| 2010-07-08 | EIR EIR | Framingham, Massachusetts | — | $550 |
| 2008-09-18 | EIR EIR | Framingham, Massachusetts | — | $550 |
| 2008-08-06 | EIR EIR | Framingham, Massachusetts | — | $550 |
| 2008-08-06 | 483 Form 483 | Framingham, Massachusetts | 6 | $99 |
| 2007-12-10 | EIR EIR | Framingham, Massachusetts | — | $550 |
Investigators on these documents
Richard H. Penta (3)Debra M. Emerson (2)Amy C. Jordan (1)Ashley M. Whitehurst (1)Douglas S. Joslin (1)Justine M. Corson (1)Lauren M. Lawrance (1)Mary McGarry (1)Michelle M. Noe (1)Nichole B. Murphy (1)Pamela L. Lee (1)Pamela L. Ogonowski (1)
FEI number 3005881167 · most recent document Nov 9, 2012
About Ameridose, LLC
How many FDA Form 483s has Ameridose, LLC received?
FDA Intel has 2 Form 483s on file for Ameridose, LLC; the most recent is dated Nov 9, 2012.
When was Ameridose, LLC last inspected by FDA?
The most recent FDA inspection document on file for Ameridose, LLC is a Form 483 dated Nov 9, 2012, for the site in Westborough, Massachusetts.
What did FDA cite at Ameridose, LLC?
The regulations cited most in the observations on file for Ameridose, LLC are 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.