New England Home Therapies, Inc.
Form 483 issued October 8, 2014 · Southborough, Massachusetts
- Inspection
- Sep 22 – Sep 26, 2014
- Investigator
- Sharon K. Thoma
- Observations
- 7
- Pages
- 5
- FEI number
- 1000120535
In short: On October 8, 2014, FDA issued a Form 483 with 7 observations to New England Home Therapies, Inc. in Southborough, Massachusetts (FEI 1000120535) after an inspection that ran Sep 22 – Sep 26, 2014. The investigator was Sharon K. Thoma. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 7 observations.
Most cited: 21 CFR 211.42 (3×)
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
Buildings used in the processing of a drug product are not maintained in a…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Sharon K. Thoma
9 documents · 2009–2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Pennsylvania.
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 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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.?
Sharon K. Thoma is named on this Form 483, for the inspection of Sep 22 – Sep 26, 2014. Each investigator has a profile showing what they cite most.
When was New England Home Therapies, Inc. inspected by FDA?
The inspection ran Sep 22 – Sep 26, 2014, and the Form 483 is dated October 8, 2014.
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.