Form 483

McClancy Foods and Flavors LLC Form 483, 2022-05-13

FDA issued a Form 483 to McClancy Foods and Flavors LLC on 2022-05-13 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

McClancy Foods and Flavors LLC · Fort Mill, United States · Issued May 13, 2022

Overview

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

13 May 2022
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Michelle L Jones, Katelynn J Rollins, Rashard A Knight, Kara D Miller

13 May 2022
21 CFR 117.135(c)(3)

Sanitation Controls Procedures

Cited by Michelle L Jones, Katelynn J Rollins, Rashard A Knight, Kara D Miller

13 May 2022
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Michelle L Jones, Katelynn J Rollins, Rashard A Knight, Kara D Miller

13 May 2022
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Michelle L Jones, Katelynn J Rollins, Rashard A Knight, Kara D Miller

13 May 2022
21 CFR 117.80(c)

Manufacturing, processing, packing, holding - Controls

Cited by Michelle L Jones, Katelynn J Rollins, Rashard A Knight, Kara D Miller

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 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 117.145(a)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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