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Form 483

Rovira Biscuit Corporation Form 483, 2019-11-26

FDA issued a Form 483 to Rovira Biscuit Corporation on 2019-11-26 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Rovira Biscuit Corporation · Ponce, United States · Issued November 26, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

26 Nov 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Miguel G Manzano

Inspected site

RBRovira Biscuit CorporationPonce, United States

Inspection team

MGMiguel G Manzano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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