Wells Pharma of Houston LLC
Form 483 issued April 13, 2026 · Houston, Texas
- Inspection
- Mar 17 – Apr 13, 2026
- Investigator
- Cameron E. Moore
- Observations
- 6
- Pages
- 7
- FEI number
- 3016710931
In short: On April 13, 2026, FDA issued a Form 483 with 6 observations to Wells Pharma of Houston LLC in Houston, Texas (FEI 3016710931) after an inspection that ran Mar 17 – Apr 13, 2026. The investigator was Cameron E. Moore. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
The written stability testing…
- 04
Ding products failing to meet established specifications and quality control…
This inspection in context
Cameron E. Moore
1 document · 2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmWells Pharma of Houston LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wells Pharma of Houston 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 Wells Pharma of Houston LLC?
Cameron E. Moore is named on this Form 483, for the inspection of Mar 17 – Apr 13, 2026. Each investigator has a profile showing what they cite most.
When was Wells Pharma of Houston LLC inspected by FDA?
The inspection ran Mar 17 – Apr 13, 2026, and the Form 483 is dated April 13, 2026.
How do I get the full Form 483 for Wells Pharma of Houston 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.