Atlas

Form 483

Paisley Farms, LLC dba Paisley Farm & Crafts Form 483, 2019-02-08

FDA issued a Form 483 to Paisley Farms, LLC dba Paisley Farm & Crafts on 2019-02-08 with 76 public-safe observations.

483· Form 483 issuedFoods & Cosmetics76 observations

Paisley Farms, LLC dba Paisley Farm & Crafts · Appalachia, United States · Issued February 8, 2019

Overview

  • 76 public-safe observations are available for this inspection.
  • 24 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.

8 Feb 2019
21 CFR 111.113(c)

Document - material review, disposition

Cited by Markeesa M Scales

8 Feb 2019
21 CFR 111.113(c)

Document - material review, disposition

Cited by Markeesa M Scales

8 Feb 2019
21 CFR 111.12(c)

Personnel - education, training, experience

Cited by Markeesa M Scales

8 Feb 2019
21 CFR 111.12(c)

Personnel - education, training, experience

Cited by Markeesa M Scales

8 Feb 2019
21 CFR 111.155(d)(1)

Components - identify lot produced

Cited by Markeesa M Scales

Inspected site

PFPaisley Farms, LLC dba Paisley Farm & CraftsAppalachia, United States

Inspection team

MMMarkeesa M Scales

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.70(e)Cited across public-safe Form 483 observations8x
21 CFR 111.155(d)(1)Cited across public-safe Form 483 observations4x
21 CFR 111.205(a)Cited across public-safe Form 483 observations4x
21 CFR 111.375(b)Cited across public-safe Form 483 observations4x
21 CFR 111.475(b)(1)Cited across public-safe Form 483 observations4x
21 CFR 111.503Cited across public-safe Form 483 observations4x
21 CFR 111.553Cited across public-safe Form 483 observations4x
21 CFR 111.65Cited across public-safe Form 483 observations4x
21 CFR 111.70(g)Cited across public-safe Form 483 observations4x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations4x
21 CFR 111.75(a)(2)(ii)(C)Cited across public-safe Form 483 observations4x
21 CFR 111.83(a)Cited across public-safe Form 483 observations4x
21 CFR 111.113(c)Cited across public-safe Form 483 observations2x
21 CFR 111.12(c)Cited across public-safe Form 483 observations2x
21 CFR 111.15(d)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.15(f)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.15(i)Cited across public-safe Form 483 observations2x
21 CFR 111.23(b)Cited across public-safe Form 483 observations2x
21 CFR 111.255(a)Cited across public-safe Form 483 observations2x
21 CFR 111.27(a)(7)Cited across public-safe Form 483 observations2x
21 CFR 111.30(c)Cited across public-safe Form 483 observations2x
21 CFR 111.35(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.365(a)Cited across public-safe Form 483 observations2x
21 CFR 111.415(f)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 76 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