New England Life Care, Inc., dba Advanced Compounding Solutions
FDA inspection history across 2 sites, 2017 to 2023
- 2
- Warning letters
- 2
- Form 483s
- 1
- Response
Every document, by year
- Warning letter
- Form 483
- Response
2017: one 483 response and one Form 483; 2019: one warning letter; 2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19One 483 response, one Form 483 and one warning letter, at Woburn, Massachusetts and Massachusetts.
- 2022–23One Form 483 and one warning letter, at Woburn, Massachusetts.
- 2022The longest 483 on file: 7 observations over 13 pages at Woburn, Massachusetts.
Cited most
Across all New England Life Care, Inc., dba Advanced Compounding Solutions observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.134Drug product inspection1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
The complete New England Life Care, Inc., dba Advanced Compounding Solutions file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Woburn, Massachusetts
Two Form 483s, one warning letter and one 483 response · 2017 to 2023 · 14 observations
Latest: Warning letter, May 16, 2023 →Massachusetts
One warning letter · 2019
Latest: Warning letter, Aug 21, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-16 | Warning letter Warning letter | Woburn, Massachusetts | — | $99 |
| 2022-04-28 | 483 Form 483 | Woburn, Massachusetts | 7 | $99 |
| 2019-08-21 | Warning letter Warning letter | Massachusetts | — | $99 |
| 2017-09-29 | Response 483 response | Woburn, Massachusetts | — | $199 |
| 2017-08-22 | 483 Form 483 | Woburn, Massachusetts | 7 | $99 |
Investigators on these documents
Erik W. Koester (2)Robert J. Martin (2)Daniel L. Zheng (1)Jonathan G. Matrisciano (1)Terry Bridgewater (1)
FEI number 3010371376 · most recent document May 16, 2023
About New England Life Care, Inc., dba Advanced Compounding Solutions
How many FDA Form 483s has New England Life Care, Inc., dba Advanced Compounding Solutions received?
FDA Intel has 2 Form 483s on file for New England Life Care, Inc., dba Advanced Compounding Solutions; the most recent is dated Apr 28, 2022.
When was New England Life Care, Inc., dba Advanced Compounding Solutions last inspected by FDA?
The most recent FDA inspection document on file for New England Life Care, Inc., dba Advanced Compounding Solutions is a Form 483 dated Apr 28, 2022, for the site in Woburn, Massachusetts.
What did FDA cite at New England Life Care, Inc., dba Advanced Compounding Solutions?
The regulations cited most in the observations on file for New England Life Care, Inc., dba Advanced Compounding Solutions are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.134 (Drug product inspection), 1 time.
Has New England Life Care, Inc., dba Advanced Compounding Solutions received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for New England Life Care, Inc., dba Advanced Compounding Solutions; the most recent is dated May 16, 2023.