New England Home Therapies, Inc.
Form 483 issued January 27, 2016 · Southborough, Massachusetts
- Inspection
- Jan 11 – Jan 27, 2016
- Investigators
- Edmund F. Mrak· Jonathan G. Matrisciano
- Observations
- 11
- Pages
- 11
- FEI number
- 1000120535
In short: On January 27, 2016, FDA issued a Form 483 with 11 observations to New England Home Therapies, Inc. in Southborough, Massachusetts (FEI 1000120535) after an inspection that ran Jan 11 – Jan 27, 2016. The investigators were Edmund F. Mrak and Jonathan G. Matrisciano. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 11 observations.
Most cited: 21 CFR 211.42 (3×) · 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
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmNew England Home Therapies, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New England Home Therapies, Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected New England Home Therapies, Inc.?
Edmund F. Mrak and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Jan 11 – Jan 27, 2016. Each investigator has a profile showing what they cite most.
When was New England Home Therapies, Inc. inspected by FDA?
The inspection ran Jan 11 – Jan 27, 2016, and the Form 483 is dated January 27, 2016.
How do I get the full Form 483 for New England Home Therapies, Inc.?
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.