Drugs · Nov 7, 2025

Wells Pharma of Houston, LLC

9 extracted findings

FDA source excerpt, selected passage

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO **(b)(4)** area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).

Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)).

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).

Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 21021 CFR 310.305(b)21 CFR 211.113(b)21 CFR 211.42(c)(10)(iv)21 CFR 211.192 21 CFR 211.22(d)21 CFR 211.125(a)21 CFR 211.42(c)(10)(v)21 CFR 211.63 21 CFR 211.42(c)(10)(vi)21 CFR 210.1(b)21 CFR 200.10(b)21 CFR 201.115

Wells Pharma of Houston, LLC

Findings and supporting evidence

Findings extracted from the letter

Sections and clauses cited

More drug letters

Keep exploring

Put this kind of reading to
work on your own records.

FDA Warning Letter Alerts

Findings and supporting evidence

Findings extracted from the letter

Sections and clauses cited

More drug letters

Keep exploring

Put this kind of reading towork on your own records.

Put this kind of reading to
work on your own records.