Form 483

Quinault Pride Seafood Form 483, 2011-05-12

FDA issued a Form 483 to Quinault Pride Seafood on 2011-05-12 with 15 public-safe observations.

483· Form 483 issued15 observations

Quinault Pride Seafood · Taholah, United States · Issued May 12, 2011

Overview

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

Inspectional observations

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

12 May 2011
21 CFR 108.35(d)

Notify FDA - spoilage

Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones

12 May 2011
21 CFR 108.35(f)

Recall procedures

Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones

12 May 2011
21 CFR 113.40(a)(2)(iii)

Adjusted to agree with TID

Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones

12 May 2011
21 CFR 113.40(a)(2)(iii)

Unauthorized adjustment

Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones

12 May 2011
21 CFR 113.40(a)(8)

Observable

Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones

Inspected site

QPQuinault Pride SeafoodTaholah, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.100(b)Cited across public-safe Form 483 observations2x
21 CFR 113.40(a)(2)(iii)Cited across public-safe Form 483 observations2x
21 CFR 113.60(a)Cited across public-safe Form 483 observations2x
21 CFR 108.35(d)Cited across public-safe Form 483 observations1x
21 CFR 108.35(f)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(13)(i)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 113.60(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 113.60(c)Cited across public-safe Form 483 observations1x
21 CFR 113.87(a)Cited across public-safe Form 483 observations1x
21 CFR 113.89Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 15 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