Form 483

Twisted PinesQual Farm, LLC Form 483, 2020-05-01

FDA issued a Form 483 to Twisted PinesQual Farm, LLC on 2020-05-01 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Twisted PinesQual Farm, LLC · Wiggins, United States · Issued May 1, 2020

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.

1 May 2020
21 CFR 108.25(c)(2)

Process filing

Cited by Debra A Taylor

1 May 2020
21 CFR 114.80(a)

Quality control procedures

Cited by Debra A Taylor

1 May 2020
21 CFR 114.80(b)

Code - required elements

Cited by Debra A Taylor

1 May 2020
21 CFR 117.10

Personnel

Cited by Debra A Taylor

1 May 2020
21 CFR 117.20(b)

Plant Construction and Design

Cited by Debra A Taylor

Inspected site

TPTwisted PinesQual Farm, LLCWiggins, United States

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 114.80(a)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited across public-safe Form 483 observations1x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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