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

Form 483 issued April 28, 2022 · Woburn, Massachusetts

Inspection: Mar 21 – Apr 28, 2022
Investigators: Daniel L. Zheng· Jonathan G. Matrisciano· Terry Bridgewater
Observations: 7
Pages: 13
FEI number: 3010371376

In short: On April 28, 2022, 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 Mar 21 – Apr 28, 2022. The investigators were Daniel L. Zheng, Jonathan G. Matrisciano and Terry Bridgewater. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and packaging & labeling account for 5 of 7 observations.

Facilities & equipment3

Packaging & labeling2

Quality system1

Production1

Most cited: 21 CFR 211.42 (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 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
02
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be…
03
21 CFR 211.42
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
04
21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…

3 more observations

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

Get the full 483

This inspection in context

The investigator

Daniel L. Zheng

24 documents · 2020–2026

Cites 211.192 (production record review) 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 211.42

See how FDA wrote the same problem up elsewhere.

Original PDF$99

✓ All 13 pages, as issued to the firm
✓ Searchable text
✓ Download right after checkout, yours to keep

I agree to the Terms of Service, the licence (internal use by my organization only, no sharing or resale) and the Refund Policy, and I ask for immediate access to the download, so I lose any right to cancel once it's available.

Get it free · first document

Secure checkout · receipt for expenses

Already bought it? Find an order

Licensed for use within your organization. No sharing or resale.

Complete the picture

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

All 5 documents for this site in one go: $506 instead of ~~$595~~, 15% off.

See the site history

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, packaging & labeling and quality system. 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 Life Care, Inc., dba Advanced Compounding Solutions?

Daniel L. Zheng, Jonathan G. Matrisciano and Terry Bridgewater are named on this Form 483, for the inspection of Mar 21 – Apr 28, 2022. 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 Mar 21 – Apr 28, 2022, and the Form 483 is dated April 28, 2022.

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

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.