FDA Inspection
Wells Pharma of Houston LLCWells Pharma of Houston LLC – FDA Inspection, Apr 13, 2026
Record Details
This FDA Inspection record concerns Wells Pharma of Houston LLC, with an inspection on April 13, 2026, issued by the Dallas District Office, covering human drugs.
View Company Profile
ID · 1b69b978-6820-44d2-93c7-77c431525aa3
Inspection Facts
- Inspection number
- 1302362
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wells Pharma of Houston LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | OAI | Dallas District Office | Drug Quality Assurance |
| December 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Wells Pharma of Houston LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.