Farmakeio Outsourcing LLC
Form 483 issued September 5, 2025 · Southlake, Texas
- Inspection
- Aug 18 – Sep 5, 2025
- Investigator
- Camerson E. Moore
- Observations
- 5
- Pages
- 6
- FEI number
- 3014982757
In short: On September 5, 2025, FDA issued a Form 483 with 5 observations to Farmakeio Outsourcing LLC in Southlake, Texas (FEI 3014982757) after an inspection that ran Aug 18 – Sep 5, 2025. The investigator was Camerson E. Moore. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.167 (special testing requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Farmakeio Outsourcing LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.167 (special testing requirements). The opening words of each observation are shown on this page.
Who inspected Farmakeio Outsourcing LLC?
Camerson E. Moore is named on this Form 483, for the inspection of Aug 18 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was Farmakeio Outsourcing LLC inspected by FDA?
The inspection ran Aug 18 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
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.