New England Life Care, Inc.
Form 483 issued March 2, 2018 · Port l a nd, Maine
- Inspection
- Feb 26 – Mar 2, 2018
- Investigator
- Edmund F. Mrak
- Observations
- 5
- Pages
- 5
- FEI number
- 1000159373
In short: On March 2, 2018, FDA issued a Form 483 with 5 observations to New England Life Care, Inc. in Port l a nd, Maine (FEI 1000159373) after an inspection that ran Feb 26 – Mar 2, 2018. The investigator was Edmund F. Mrak. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 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
You had inadequate HEPA filter coverage and airflow over the area to which…
- 02
You produced beta-lactam drugs without providing adequate containment, segregation and cleaning of work…
- 03
Materials or supplies were not disinfected prior to entering…
- 04
Personnel engaged in aseptic processing were…
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 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 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 Life Care, Inc.?
Edmund F. Mrak is named on this Form 483, for the inspection of Feb 26 – Mar 2, 2018. Each investigator has a profile showing what they cite most.
When was New England Life Care, Inc. inspected by FDA?
The inspection ran Feb 26 – Mar 2, 2018, and the Form 483 is dated March 2, 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.