New England Home Therapies, Inc.
FDA inspection history in Southborough, Massachusetts, 2014 to 2016
- 2
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Two Form 483s, at Southborough, Massachusetts.
- 2016The longest 483 on file: 11 observations over 11 pages at Southborough, Massachusetts.
Cited most
Across all New England Home Therapies observations on file
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.58Maintenance2
- 21 CFR 211.165Testing and release for distribution1
The complete New England Home Therapies file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Southborough, Massachusetts
Two Form 483s · 2014 to 2016 · 18 observations
Latest: Form 483, Jan 27, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-01-27 | 483 Form 483 | Southborough, Massachusetts | 11 | $99 |
| 2014-10-08 | 483 Form 483 | Southborough, Massachusetts | 7 | $99 |
Investigators on these documents
Edmund F. Mrak (1)Jonathan G. Matrisciano (1)Sharon K. Thoma (1)
FEI number 1000120535 · most recent document Jan 27, 2016
About New England Home Therapies, Inc.
How many FDA Form 483s has New England Home Therapies, Inc. received?
FDA Intel has 2 Form 483s on file for New England Home Therapies, Inc.; the most recent is dated Jan 27, 2016.
When was New England Home Therapies, Inc. last inspected by FDA?
The most recent FDA inspection document on file for New England Home Therapies, Inc. is a Form 483 dated Jan 27, 2016, for the site in Southborough, Massachusetts.
What did FDA cite at New England Home Therapies, Inc.?
The regulations cited most in the observations on file for New England Home Therapies, Inc. are 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.