Form 483

Daniels Seafood Company Form 483, 2011-08-03

FDA issued a Form 483 to Daniels Seafood Company on 2011-08-03 with 10 public-safe observations.

483· Form 483 issued10 observations

Daniels Seafood Company · Nags Head, United States · Issued August 3, 2011

Overview

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

Inspectional observations

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

3 Aug 2011
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Richard L Garcia, Billy M Battles

3 Aug 2011
21 CFR 110.10(b)(6)

Failure to wear

Cited by Richard L Garcia, Billy M Battles

3 Aug 2011
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Richard L Garcia, Billy M Battles

3 Aug 2011
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Richard L Garcia, Billy M Battles

3 Aug 2011
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Richard L Garcia, Billy M Battles

Inspected site

DSDaniels Seafood CompanyNags Head, United States

Inspection team

BMBilly M Battles

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(b)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