Form 483

Jones-Wrench & Wrench LLC DBA Santa Fe Ole' Food Company Form 483, 2013-11-15

FDA issued a Form 483 to Jones-Wrench & Wrench LLC DBA Santa Fe Ole' Food Company on 2013-11-15 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Jones-Wrench & Wrench LLC DBA Santa Fe Ole' Food Company · Santa Fe, United States · Issued November 15, 2013

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.

15 Nov 2013
21 CFR 108.25(c)(2)

Process filing

Cited by Brittany R Laymon

15 Nov 2013
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Brittany R Laymon

15 Nov 2013
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Brittany R Laymon

15 Nov 2013
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Brittany R Laymon

15 Nov 2013
21 CFR 114.80(a)(4)

Container testing

Cited by Brittany R Laymon

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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