Form 483

Lexington Style Trimmings Form 483, 2011-09-13

FDA issued a Form 483 to Lexington Style Trimmings on 2011-09-13 with 6 public-safe observations.

483· Form 483 issued6 observations

Lexington Style Trimmings · Lexington, United States · Issued September 13, 2011

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.

13 Sep 2011
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Mancia R Walker

13 Sep 2011
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Mancia R Walker

13 Sep 2011
21 CFR 110.20(b)(7)

Screening

Cited by Mancia R Walker

13 Sep 2011
21 CFR 110.37(d)(3)

Self-closing doors

Cited by Mancia R Walker

13 Sep 2011
21 CFR 110.80

Reasonable precautions

Cited by Mancia R Walker

Inspected site

LSLexington Style TrimmingsLexington, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

Every observation in full, 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