Farmakeio Outsourcing LLC
Form 483 issued June 10, 2022 · Southlake, Texas
- Inspection
- Jun 1 – Jun 10, 2022
- Investigators
- Patty P. Kaewussdangkul· Steven A. Brettler
- Observations
- 7
- Pages
- 5
- FEI number
- 3014982757
In short: On June 10, 2022, FDA issued a Form 483 with 7 observations to Farmakeio Outsourcing LLC in Southlake, Texas (FEI 3014982757) after an inspection that ran Jun 1 – Jun 10, 2022. The investigators were Patty P. Kaewussdangkul and Steven A. Brettler. Most observations concern laboratory controls and packaging & labeling.
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: FDCA 503B(a)(10) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Dmg products do not bear an expiration date determined by appropriate stability data to assure they…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
Written procedures are not drafted, reviewed and approved by…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Farmakeio Outsourcing LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, packaging & labeling and production. The opening words of each observation are shown on this page.
Who inspected Farmakeio Outsourcing LLC?
Patty P. Kaewussdangkul and Steven A. Brettler are named on this Form 483, for the inspection of Jun 1 – Jun 10, 2022. Each investigator has a profile showing what they cite most.
When was Farmakeio Outsourcing LLC inspected by FDA?
The inspection ran Jun 1 – Jun 10, 2022, and the Form 483 is dated June 10, 2022.
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.