Wells Pharma of Houston LLC
Form 483 issued March 28, 2025 · Houston, Texas
- Inspection
- Mar 17 – Mar 28, 2025
- Investigator
- Jazmine N. Brown
- Observations
- 9
- Pages
- 13
- FEI number
- 3016710931
In short: On March 28, 2025, FDA issued a Form 483 with 9 observations to Wells Pharma of Houston LLC in Houston, Texas (FEI 3016710931) after an inspection that ran Mar 17 – Mar 28, 2025. The investigator was Jazmine N. Brown. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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(b)
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 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Wells Pharma of Houston LLC?
Jazmine N. Brown is named on this Form 483, for the inspection of Mar 17 – Mar 28, 2025. 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 – Mar 28, 2025, and the Form 483 is dated March 28, 2025.
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.