Form 483

McClancy Foods and Flavors LLC Form 483, 2019-06-28

FDA issued a Form 483 to McClancy Foods and Flavors LLC on 2019-06-28 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

McClancy Foods and Flavors LLC · Fort Mill, United States · Issued June 28, 2019

Overview

  • 12 public-safe observations are available for this inspection.
  • 9 structured CFR citations are represented.
  • 4 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

28 Jun 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Shayla G Turnipseed, Young Kim, Laura D Cain, Katelynn J Rollins

28 Jun 2019
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Shayla G Turnipseed, Young Kim, Laura D Cain, Katelynn J Rollins

28 Jun 2019
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Shayla G Turnipseed, Young Kim, Laura D Cain, Katelynn J Rollins

28 Jun 2019
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Shayla G Turnipseed, Young Kim, Laura D Cain, Katelynn J Rollins

28 Jun 2019
21 CFR 117.145(a)

Sanitation Controls Monitoring Proced: Establish Implement

Cited by Shayla G Turnipseed, Young Kim, Laura D Cain, Katelynn J Rollins

Inspected site

MFMcClancy Foods and Flavors LLCFort Mill, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations3x
21 CFR 117.165(b)Cited across public-safe Form 483 observations2x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.150(d)Cited across public-safe Form 483 observations1x
21 CFR 117.20(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 observations

The full inspection record, as Atlas holds it, 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