New England Compounding Center
Form 483 issued October 26, 2012 · Framingham, Massachusetts
- Inspection
- Oct 1 – Oct 26, 2012
- Investigator
- Philip Kreiter
- Observations
- 5
- Pages
- 8
- FEI number
- 3003623877
In short: On October 26, 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 1 – Oct 26, 2012. The investigator was Philip Kreiter. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The environmental monitoring procedure requires sampling via personnel touch plates taken upon completion of sterile compounding…
- 02
The conditions listed below were identified during the inspection in areas used for the preparation, fi…
This inspection in context
Philip Kreiter
5 documents · 2012–2013
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 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?
Philip Kreiter is named on this Form 483, for the inspection of Oct 1 – 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 1 – Oct 26, 2012, and the Form 483 is dated October 26, 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.