New England Compounding Center
Form 483 issued November 1, 2012 · Framingham, Massachusetts
- Inspection
- Oct 26, 2012
- Investigators
- Almaris N. Alonso· Debra M. Emerson· Philip Kreiter
- Observations
- 5
- Pages
- 8
- FEI number
- 3003623877
In short: On November 1, 2012, FDA issued a Form 483 with 5 observations to New England Compounding Center in Framingham, Massachusetts (FEI 3003623877) after an inspection that ran Oct 26, 2012. The investigators were Almaris N. Alonso, Debra M. Emerson, Philip Kreiter, Stacey S. Degarmo and Thomas W. Nemey. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Although the formula worksheets state the raw materials are sterile, the Pharmacy Director stated that the…
- 03
The firm’s environmental monitoring program yielded the following microbial isolates (bacteria and mold) within Clean Room…
- 04
The environmental monitoring procedure requires sampling via personnel touch plates taken upon completion of sterile compounding…
This inspection in context
Almaris N. Alonso
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 firmNew England Compounding Center history
All 10 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 New England Compounding Center?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 New England Compounding Center?
Almaris N. Alonso, Debra M. Emerson, Philip Kreiter, Stacey S. Degarmo and Thomas W. Nemey are named on this Form 483, for the inspection of Oct 26, 2012. Each investigator has a profile showing what they cite most.
When was New England Compounding Center inspected by FDA?
The inspection ran Oct 26, 2012, and the Form 483 is dated November 1, 2012.
How do I get the full Form 483 for New England Compounding Center?
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.