Atlas

Form 483

PEPE INT C/O THE INN AT SPANISHBAY Form 483, 2018-09-21

FDA issued a Form 483 to PEPE INT C/O THE INN AT SPANISHBAY on 2018-09-21 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

PEPE INT C/O THE INN AT SPANISHBAY · Carmel, United States · Issued September 21, 2018

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.

21 Sep 2018
21 CFR 1.512(b)(1)(i)(A)

Definition very small importer

Cited by Steven B Chiu

Inspected site

PIPEPE INT C/O THE INN AT SPANISHBAYCarmel, United States

Inspection team

SBSteven B Chiu

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.512(b)(1)(i)(A)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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