Safecor Health, LLC
Form 483 issued March 16, 2023 · Woburn, Massachusetts
- Inspection
- Mar 7 – Mar 16, 2023
- Investigators
- Karen A. Briggs· Sean R. Marcsisin
- Observations
- 6
- Pages
- 8
- FEI number
- 1218914
In short: On March 16, 2023, FDA issued a Form 483 with 6 observations to Safecor Health, LLC in Woburn, Massachusetts (FEI 1218914) after an inspection that ran Mar 7 – Mar 16, 2023. The investigators were Karen A. Briggs and Sean R. Marcsisin. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Inspection of the packaging and labeling facilities immediately before use is not done to assure that…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
The preparation of your master production and control records was not followed in accordance…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmSafecor Health, LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safecor Health, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Safecor Health, LLC?
Karen A. Briggs and Sean R. Marcsisin are named on this Form 483, for the inspection of Mar 7 – Mar 16, 2023. Each investigator has a profile showing what they cite most.
When was Safecor Health, LLC inspected by FDA?
The inspection ran Mar 7 – Mar 16, 2023, and the Form 483 is dated March 16, 2023.
How do I get the full Form 483 for Safecor Health, LLC?
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.