Farmakeio Outsourcing LLC
Form 483 issued October 30, 2019 · Southlake, Texas
- Inspection
- Oct 22 – Oct 30, 2019
- Investigator
- Francis Guidry
- Observations
- 3
- Pages
- 2
- FEI number
- 3014982757
In short: On October 30, 2019, FDA issued a Form 483 with 3 observations to Farmakeio Outsourcing LLC in Southlake, Texas (FEI 3014982757) after an inspection that ran Oct 22 – Oct 30, 2019. The investigator was Francis Guidry. Most observations concern packaging & labeling and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Packaging & labeling and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Aseptic processing areas are deficient regarding the system…
This inspection in context
Francis Guidry
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Louisiana.
The firmFarmakeio Outsourcing LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Farmakeio Outsourcing LLC?
FDA listed 3 observations on this Form 483, mostly about packaging & labeling, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Farmakeio Outsourcing LLC?
Francis Guidry is named on this Form 483, for the inspection of Oct 22 – Oct 30, 2019. Each investigator has a profile showing what they cite most.
When was Farmakeio Outsourcing LLC inspected by FDA?
The inspection ran Oct 22 – Oct 30, 2019, and the Form 483 is dated October 30, 2019.
How do I get the full Form 483 for Farmakeio Outsourcing 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.