Form 483

Rushing Waters Fisheries, LLC Form 483, 2013-05-08

FDA issued a Form 483 to Rushing Waters Fisheries, LLC on 2013-05-08 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Rushing Waters Fisheries, LLC · Palmyra, United States · Issued May 8, 2013

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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 May 2013
21 CFR 123.6(b)

HACCP plan implementation

Cited by Catherine M Vanderhoef

8 May 2013
21 CFR 123.6(c)(2)

Critical control points

Cited by Catherine M Vanderhoef

8 May 2013
21 CFR 123.6(c)(3)

Critical limits

Cited by Catherine M Vanderhoef

8 May 2013
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Catherine M Vanderhoef

8 May 2013
21 CFR 123.6(c)(7)

Records values/observations

Cited by Catherine M Vanderhoef

Inspected site

RWRushing Waters Fisheries, LLCPalmyra, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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