Form 483

RLC Labs Inc. Form 483, 2021-11-04

FDA issued a Form 483 to RLC Labs Inc. on 2021-11-04 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

RLC Labs Inc. · Phoenix, United States · Issued November 4, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

4 Nov 2021
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Christopher M Jenner

4 Nov 2021
21 CFR 211.68(b)

Backup data not assured as exact and complete

Cited by Christopher M Jenner

Inspected site

RLRLC Labs Inc.Phoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 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