Wells Pharma of Houston LLC
Form 483 issued December 14, 2022 · Houston, Texas
- Inspection
- Nov 16 – Dec 14, 2022
- Investigator
- Camerson E. Moore
- Observations
- 3
- Pages
- 3
- FEI number
- 3016710931
In short: On December 14, 2022, FDA issued a Form 483 with 3 observations to Wells Pharma of Houston LLC in Houston, Texas (FEI 3016710931) after an inspection that ran Nov 16 – Dec 14, 2022. The investigator was Camerson E. Moore. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection and checking of automatic and electronic equipment is not performed according to a written…
- 02
Buildings used in the manufacture, processing, packing, or holding of a diug product do not have…
- 03
The responsibilities and procedures applicable to the quality control unit…
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 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 211.68(a)
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 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Wells Pharma of Houston LLC?
Camerson E. Moore is named on this Form 483, for the inspection of Nov 16 – Dec 14, 2022. Each investigator has a profile showing what they cite most.
When was Wells Pharma of Houston LLC inspected by FDA?
The inspection ran Nov 16 – Dec 14, 2022, and the Form 483 is dated December 14, 2022.
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.