Safecor Health, LLC
FDA inspection history across 2 sites, 2011 to 2024
- 5
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2011: one Form 483; 2015: one Form 483; 2017: one Form 483; 2023: one warning letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Woburn, Massachusetts.
- 2015–17Two Form 483s, at Woburn, Massachusetts.
- 2015The longest 483 on file: 13 observations over 10 pages at Woburn, Massachusetts.
- 2023–24Two Form 483s and one warning letter, at Columbus, Ohio and Woburn, Massachusetts.
Cited most
Across all Safecor Health observations on file
- 21 CFR 211.198Complaint files4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
The complete Safecor Health file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Woburn, Massachusetts
Five Form 483s · 2011 to 2024 · 35 observations
Latest: Form 483, Jun 24, 2024 →Columbus, Ohio
One warning letter and one close-out letter · 2023
Latest: Warning letter, Sep 5, 2023 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-24 | 483 Form 483 | Woburn, Massachusetts | 3 | $99 |
| 2023-09-05 | Warning letter Warning letter | Columbus, Ohio | — | $99 |
| 2023-03-16 | 483 Form 483 | Woburn, Massachusetts | 6 | $99 |
| 2017-10-19 | 483 Form 483 | Woburn, Massachusetts | 7 | $99 |
| 2015-10-27 | 483 Form 483 | Woburn, Massachusetts | 13 | $99 |
| 2011-03-07 | 483 Form 483 | Woburn, Massachusetts | 6 | $99 |
| Undated | Close-out Close-out letter | Columbus, Ohio | — | $99 |
Investigators on these documents
Erik W. Koester (3)Robert J. Martin (2)Divek R. Jumani (1)Karen A. Briggs (1)Rory Geyer (1)Sean R. Marcsisin (1)
FEI number 1218914 · most recent document Jun 24, 2024
About Safecor Health, LLC
How many FDA Form 483s has Safecor Health, LLC received?
FDA Intel has 5 Form 483s on file for Safecor Health, LLC; the most recent is dated Jun 24, 2024.
When was Safecor Health, LLC last inspected by FDA?
The most recent FDA inspection document on file for Safecor Health, LLC is a Form 483 dated Jun 24, 2024, for the site in Woburn, Massachusetts.
What did FDA cite at Safecor Health, LLC?
The regulations cited most in the observations on file for Safecor Health, LLC are 21 CFR 211.198 (Complaint files), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.192 (Production record review), 3 times.
Has Safecor Health, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Safecor Health, LLC; the most recent is dated Sep 5, 2023.