GEO Specialty Chemicals, Inc
Form 483 issued October 10, 2024 · Deer Park, Texas
- Inspection
- Oct 7 – Oct 10, 2024
- Investigator
- Timothy H. Vo
- Observations
- 3
- Pages
- 3
- FEI number
- 1629689
In short: On October 10, 2024, FDA issued a Form 483 with 3 observations to GEO Specialty Chemicals, Inc in Deer Park, Texas (FEI 1629689) after an inspection that ran Oct 7 – Oct 10, 2024. The investigator was Timothy H. Vo. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.194 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish, document, and implement an effective system for managing quality that involves the active…
- 02
Failure to have laboratory control records that maintain complete data derived from all laboratory tests conducted…
- 03
Failure to have written and approve contracts or formal agreements between the contract giver and contract…
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 firmGEO Specialty Chemicals, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GEO Specialty Chemicals, Inc?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected GEO Specialty Chemicals, Inc?
Timothy H. Vo is named on this Form 483, for the inspection of Oct 7 – Oct 10, 2024. Each investigator has a profile showing what they cite most.
When was GEO Specialty Chemicals, Inc inspected by FDA?
The inspection ran Oct 7 – Oct 10, 2024, and the Form 483 is dated October 10, 2024.
How do I get the full Form 483 for GEO Specialty Chemicals, Inc?
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.