Form 483

Rojas RM, Inc. Form 483, 2017-06-05

FDA issued a Form 483 to Rojas RM, Inc. on 2017-06-05 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Rojas RM, Inc. · Chula Vista, United States · Issued June 5, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

5 Jun 2017
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Geoffrey M Leist

5 Jun 2017
21 CFR 110.20(b)(7)

Screening

Cited by Geoffrey M Leist

5 Jun 2017
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Geoffrey M Leist

Inspected site

RRRojas RM, Inc.Chula Vista, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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