Safecor Health, LLC
Form 483 issued March 7, 2011 · Woburn, Massachusetts
- Inspection
- Feb 15 – Mar 7, 2011
- Investigator
- Rory Geyer
- Observations
- 6
- Pages
- 6
- FEI number
- 1218914
In short: On March 7, 2011, FDA issued a Form 483 with 6 observations to Safecor Health, LLC in Woburn, Massachusetts (FEI 1218914) after an inspection that ran Feb 15 – Mar 7, 2011. The investigator was Rory Geyer. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 03
The flow of drug products though the building is not…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Rory Geyer
2 documents · 2011–2012
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 211.192
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 facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Safecor Health, LLC?
Rory Geyer is named on this Form 483, for the inspection of Feb 15 – Mar 7, 2011. Each investigator has a profile showing what they cite most.
When was Safecor Health, LLC inspected by FDA?
The inspection ran Feb 15 – Mar 7, 2011, and the Form 483 is dated March 7, 2011.
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.