Safecor Health, LLC
Form 483 issued October 27, 2015 · Woburn, Massachusetts
- Inspection
- Oct 5 – Oct 27, 2015
- Investigators
- Erik W. Koester· Robert J. Martin
- Observations
- 13
- Pages
- 10
- FEI number
- 1218914
In short: On October 27, 2015, FDA issued a Form 483 with 13 observations to Safecor Health, LLC in Woburn, Massachusetts (FEI 1218914) after an inspection that ran Oct 5 – Oct 27, 2015. The investigators were Erik W. Koester and Robert J. Martin. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safecor Health, LLC?
FDA listed 13 observations on this Form 483, mostly about quality system, laboratory controls 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 5 – Oct 27, 2015. Each investigator has a profile showing what they cite most.
When was Safecor Health, LLC inspected by FDA?
The inspection ran Oct 5 – Oct 27, 2015, and the Form 483 is dated October 27, 2015.
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.