Form 483

Wells Pharma of Houston LLC Form 483, 2026-04-13

FDA issued a Form 483 to Wells Pharma of Houston LLC on 2026-04-13 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Wells Pharma of Houston LLC · Houston, United States · Issued April 13, 2026

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

WPWells Pharma of Houston LLCHouston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
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 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere