New England Life Care, Inc., dba Advanced Compounding Solutions

Form 483 issued August 22, 2017 · Woburn, Massachusetts

Inspection: Aug 2 – Aug 22, 2017
Investigators: Erik W. Koester· Robert J. Martin
Observations: 7
Pages: 6
FEI number: 3010371376

In short: On August 22, 2017, FDA issued a Form 483 with 7 observations to New England Life Care, Inc., dba Advanced Compounding Solutions in Woburn, Massachusetts (FEI 3010371376) after an inspection that ran Aug 2 – Aug 22, 2017. The investigators were Erik W. Koester and 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

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment2

Production2

Laboratory controls1

Materials1

Other1

Most cited: 21 CFR 211.113 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.165
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
02
21 CFR 211.42
Aseptic processing areas are deficient regarding the system…
03
21 CFR 211.46
Observation 3: scanned text, readable in the full document.
04
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Erik W. Koester

40 documents · 2006–2026

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.

The firm

New England Life Care, Inc., dba Advanced Compounding Solutions history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Sep 29, 2017$199

New England Life Care, Inc., dba Advanced Compounding Solutions site file

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Questions about this 483

What did FDA find at New England Life Care, Inc., dba Advanced Compounding Solutions?

FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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., dba Advanced Compounding Solutions?

Erik W. Koester and Robert J. Martin are named on this Form 483, for the inspection of Aug 2 – Aug 22, 2017. Each investigator has a profile showing what they cite most.

When was New England Life Care, Inc., dba Advanced Compounding Solutions inspected by FDA?

The inspection ran Aug 2 – Aug 22, 2017, and the Form 483 is dated August 22, 2017.

How do I get the full Form 483 for New England Life Care, Inc., dba Advanced Compounding Solutions?

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