Safecor Health, LLC
Form 483 issued June 24, 2024 · Woburn, Massachusetts
- Inspection
- Jun 10 – Jun 24, 2024
- Investigators
- Divek R. Jumani· Erik W. Koester
- Observations
- 3
- Pages
- 4
- FEI number
- 1218914
In short: On June 24, 2024, FDA issued a Form 483 with 3 observations to Safecor Health, LLC in Woburn, Massachusetts (FEI 1218914) after an inspection that ran Jun 10 – Jun 24, 2024. The investigators were Divek R. Jumani and Erik W. Koester. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written procedures are not followed for evaluations done at least annually and including provisions for a…
This inspection in context
Divek R. Jumani
5 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
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 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safecor Health, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Safecor Health, LLC?
Divek R. Jumani and Erik W. Koester are named on this Form 483, for the inspection of Jun 10 – Jun 24, 2024. Each investigator has a profile showing what they cite most.
When was Safecor Health, LLC inspected by FDA?
The inspection ran Jun 10 – Jun 24, 2024, and the Form 483 is dated June 24, 2024.
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.