Form 483

SAN-REY PRODUCE Form 483, 2023-07-18

FDA issued a Form 483 to SAN-REY PRODUCE on 2023-07-18 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

SAN-REY PRODUCE · Pharr, United States · Issued July 18, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

18 Jul 2023
21 CFR 1.502(a)

Develop FSVP

Cited by Connie Lucero, Michael I Morgan

18 Jul 2023
21 CFR 1.509(a)

Identification - entry

Cited by Connie Lucero, Michael I Morgan

Inspected site

SPSAN-REY PRODUCEPharr, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.509(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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