Form 483

McClancy Foods and Flavors LLC Form 483, 2023-01-13

FDA issued a Form 483 to McClancy Foods and Flavors LLC on 2023-01-13 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

McClancy Foods and Flavors LLC · Fort Mill, United States · Issued January 13, 2023

Overview

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

Inspectional observations

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

13 Jan 2023
21 CFR 117.190(a)

Sanitation preventive controls - Implementation records

Cited by Katelynn J Rollins, Rashard A Knight, Gates E Raynor

13 Jan 2023
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Katelynn J Rollins, Rashard A Knight, Gates E Raynor

13 Jan 2023
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Katelynn J Rollins, Rashard A Knight, Gates E Raynor

13 Jan 2023
21 CFR 117.410(c)

Supply-chain program - Assurance (Adequate)

Cited by Katelynn J Rollins, Rashard A Knight, Gates E Raynor

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 117.190(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 117.410(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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