FDA Inspection
Wells Pharma of Houston LLCWells Pharma of Houston LLC – FDA Inspection, Mar 28, 2025
Record Details
This FDA Inspection record concerns Wells Pharma of Houston LLC, with an inspection on March 28, 2025, issued by the Dallas District Office, covering human drugs.
- Office
- Dallas District Office
- Person
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ID · e551c869-05e4-4af7-8e72-26e70172f5b4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1266232
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- FDCA 503B(a)(10)(A)Drug product labels, fails to include
- FDCA 503B(b)(2)(A)All inclusive product report, not submitted
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Other FDA inspections of Wells Pharma of Houston LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2026 | Not classified | 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 |
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