Form 483

Miracles In Sight Lone Star Division Form 483, 2011-07-25

FDA issued a Form 483 to Miracles In Sight Lone Star Division on 2011-07-25 with 4 public-safe observations.

483· Form 483 issued4 observations

Miracles In Sight Lone Star Division · Manor, United States · Issued July 25, 2011

Overview

  • 4 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.

25 Jul 2011
21 CFR 1271.55(d)(4)

Ten year retention

Cited by Iris C Macinnes

25 Jul 2011
21 CFR 1271.200(a)

Cleaned, sanitized per established schedules

Cited by Iris C Macinnes

25 Jul 2011
21 CFR 1271.260(e)

Periodic review of temperatures

Cited by Iris C Macinnes

25 Jul 2011
21 CFR 1271.260(e)

Storage temperatures recorded, maintained

Cited by Iris C Macinnes

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.260(e)Cited across public-safe Form 483 observations2x
21 CFR 1271.200(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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