Safecor Health, LLC
Form 483 issued October 19, 2017 · Woburn, Massachusetts
- Inspection
- Oct 4 – Oct 19, 2017
- Investigators
- Erik W. Koester· Robert J. Martin
- Observations
- 7
- Pages
- 7
- FEI number
- 1218914
In short: On October 19, 2017, FDA issued a Form 483 with 7 observations to Safecor Health, LLC in Woburn, Massachusetts (FEI 1218914) after an inspection that ran Oct 4 – Oct 19, 2017. The investigators were Erik W. Koester and Robert J. Martin. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safecor Health, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected Safecor Health, LLC?
Erik W. Koester and Robert J. Martin are named on this Form 483, for the inspection of Oct 4 – Oct 19, 2017. Each investigator has a profile showing what they cite most.
When was Safecor Health, LLC inspected by FDA?
The inspection ran Oct 4 – Oct 19, 2017, and the Form 483 is dated October 19, 2017.
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.