FDA-Inspected Site

Wells Pharma of Houston LLC

4 FDA inspections are on record for Wells Pharma of Houston LLC in Houston, United States.

483· Form 483 issued

Houston, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-13.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Mar 2026 – 13 Apr 2026Human Drugs483View 483 →
17 Mar 2025 – 28 Mar 2025Human DrugsWLView 483 →
16 Nov 2022 – 14 Dec 2022Human Drugs483View 483 →
25 May 2021 – 17 Jun 2021Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

13 Apr 2026
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Camerson E Moore

13 Apr 2026
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Camerson E Moore

13 Apr 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Camerson E Moore

13 Apr 2026
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Camerson E Moore

13 Apr 2026
21 CFR 211.166(a)

Written program not followed

Cited by Camerson E Moore

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.125(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
FDCA 503B(a)(10)(A)Cited across public-safe Form 483 observations1x
FDCA 503B(b)(2)(A)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Wells Pharma of Houston LLC's 4 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat