Seatex LLC
Form 483 issued October 20, 2023 · Rosenberg, Texas
- Inspection
- Oct 16 – Oct 20, 2023
- Investigator
- Timothy H. Vo
- Observations
- 6
- Pages
- 4
- FEI number
- 3007709579
In short: On October 20, 2023, FDA issued a Form 483 with 6 observations to Seatex LLC in Rosenberg, Texas (FEI 3007709579) after an inspection that ran Oct 16 – Oct 20, 2023. The investigator was Timothy H. Vo. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls c o not include the establishment of scientifically sound and appropriate specifications and test…
- 02
Control procedures are not established which of those manufacturing processes that may be responsible for causing…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Timothy H. Vo
9 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmSeatex LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Seatex LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Seatex LLC?
Timothy H. Vo is named on this Form 483, for the inspection of Oct 16 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was Seatex LLC inspected by FDA?
The inspection ran Oct 16 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
How do I get the full Form 483 for Seatex 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.