Form 483

Right Value Drug Stores LLC Form 483, 2024-06-21

FDA issued a Form 483 to Right Value Drug Stores LLC on 2024-06-21 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

Right Value Drug Stores LLC · Irving, United States · Issued June 21, 2024

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

21 Jun 2024
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Camerson E Moore

21 Jun 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Camerson E Moore

21 Jun 2024
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Camerson E Moore

21 Jun 2024
21 CFR 211.67(b)(5)

Cleaning SOPs/equipment protection

Cited by Camerson E Moore

21 Jun 2024
21 CFR 211.94(c)

Containers & Closures Clean, Sterilized, Pyrogen-free

Cited by Camerson E Moore

Inspected site

RVRight Value Drug Stores LLCIrving, 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 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.94(c)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 5 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