Form 483

Wells Pharma of Houston LLC Form 483, 2022-12-14

FDA issued a Form 483 to Wells Pharma of Houston LLC on 2022-12-14 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Wells Pharma of Houston LLC · Houston, United States · Issued December 14, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

14 Dec 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Camerson E Moore

14 Dec 2022
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Camerson E Moore

14 Dec 2022
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

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 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, 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