Form 483

Mecox Bay Dairy Form 483, 2014-09-15

FDA issued a Form 483 to Mecox Bay Dairy on 2014-09-15 with 13 public-safe observations.

483· Form 483 issuedFoods & Cosmetics13 observations

Mecox Bay Dairy · Bridgehampton, United States · Issued September 15, 2014

Overview

  • 13 public-safe observations are available for this inspection.
  • 13 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.

15 Sep 2014
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Nicole Vaught, Andrew J Garufi

15 Sep 2014
21 CFR 110.10(b)(2)

Personal cleanliness

Cited by Nicole Vaught, Andrew J Garufi

15 Sep 2014
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Nicole Vaught, Andrew J Garufi

15 Sep 2014
21 CFR 110.10(b)(6)

Failure to wear

Cited by Nicole Vaught, Andrew J Garufi

15 Sep 2014
21 CFR 110.20(a)(1)

Harborage areas

Cited by Nicole Vaught, Andrew J Garufi

Inspected site

MBMecox Bay DairyBridgehampton, United States

Inspection team

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)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)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(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)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
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 13 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