New England Life Care, Inc.
Form 483 issued February 8, 2018 · Woburn, Massachusetts
- Inspection
- Jan 31 – Feb 8, 2018
- Investigator
- Robert J. Martin
- Observations
- 5
- Pages
- 5
- FEI number
- 3014174643
In short: On February 8, 2018, FDA issued a Form 483 with 5 observations to New England Life Care, Inc. in Woburn, Massachusetts (FEI 3014174643) after an inspection that ran Jan 31 – Feb 8, 2018. The investigator was Robert J. Martin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel moved rapidly in the vicinity of open sterile units and instn nnents, which dismpted the…
- 02
You had inadequate HEPA filter coverage and airflow over the area to which…
- 03
You produced beta-lactam diugs without providing adequate cleaning of utensils…
- 04
Non-microbial contamination was observed…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNew England Life Care, Inc. history
The site's inspection history, in date order.
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 Life Care, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. 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 Life Care, Inc.?
Robert J. Martin is named on this Form 483, for the inspection of Jan 31 – Feb 8, 2018. Each investigator has a profile showing what they cite most.
When was New England Life Care, Inc. inspected by FDA?
The inspection ran Jan 31 – Feb 8, 2018, and the Form 483 is dated February 8, 2018.
How do I get the full Form 483 for New England Life Care, 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.