Wells Pharma of Houston LLC
Form 483 issued June 17, 2021 · Houston, Texas
- Inspection
- May 25 – Jun 17, 2021
- Investigator
- Stephen D. Brown
- Observations
- 1
- Pages
- 2
- FEI number
- 3016710931
In short: On June 17, 2021, FDA issued a Form 483 with 1 observation to Wells Pharma of Houston LLC in Houston, Texas (FEI 3016710931) after an inspection that ran May 25 – Jun 17, 2021. The investigator was Stephen D. Brown. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
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(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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Wells Pharma of Houston LLC?
Stephen D. Brown is named on this Form 483, for the inspection of May 25 – Jun 17, 2021. Each investigator has a profile showing what they cite most.
When was Wells Pharma of Houston LLC inspected by FDA?
The inspection ran May 25 – Jun 17, 2021, and the Form 483 is dated June 17, 2021.
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.