Ameridose, LLC
Form 483 issued November 9, 2012 · Westborough, Massachusetts
- Inspection
- Oct 10 – Nov 9, 2012
- Investigators
- Allison A. Rodriguez· Almaria N. Alonso· Amy C. Jordan
- Observations
- 15
- Pages
- 20
- FEI number
- 3005881167
In short: On November 9, 2012, FDA issued a Form 483 with 15 observations to Ameridose, LLC in Westborough, Massachusetts (FEI 3005881167) after an inspection that ran Oct 10 – Nov 9, 2012. The investigators were Allison A. Rodriguez, Almaria N. Alonso, Amy C. Jordan, Ashley M. Whitehurst, Douglas S. Joslin, Justine M. Corson, Lauren M. Lawrance, Mary McGarry, Nichole B. Murphy, Pamela L. Lee, Pamela L. Ogonowski, Philip Kreiter, Ramon E. Martinez, Rory Geyer and Slater K. Bartlett. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Facilities & equipment and laboratory controls account for 9 of 15 observations.
Most cited: 21 CFR 211.165 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Allison A. Rodriguez
1 document · 2012
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAmeridose, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ameridose, LLC?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Ameridose, LLC?
Allison A. Rodriguez, Almaria N. Alonso, Amy C. Jordan, Ashley M. Whitehurst, Douglas S. Joslin, Justine M. Corson, Lauren M. Lawrance, Mary McGarry, Nichole B. Murphy, Pamela L. Lee, Pamela L. Ogonowski, Philip Kreiter, Ramon E. Martinez, Rory Geyer and Slater K. Bartlett are named on this Form 483, for the inspection of Oct 10 – Nov 9, 2012. Each investigator has a profile showing what they cite most.
When was Ameridose, LLC inspected by FDA?
The inspection ran Oct 10 – Nov 9, 2012, and the Form 483 is dated November 9, 2012.
How do I get the full Form 483 for Ameridose, LLC?
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.