Atlas

Form 483

Industria Lechera de P.R., Inc. Form 483, 2014-07-23

FDA issued a Form 483 to Industria Lechera de P.R., Inc. on 2014-07-23 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Industria Lechera de P.R., Inc. · San Juan, United States · Issued July 23, 2014

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.

23 Jul 2014
21 CFR 110.80

Reasonable precautions

Cited by Jorge L Lajara

23 Jul 2014
21 CFR 113.40(g)(1)(i)(B)(3)

Adjusted to agree with TID

Cited by Jorge L Lajara

23 Jul 2014
21 CFR 113.40(g)(1)(i)(E)

Differential pressure recorder-controller sensor - accuracy

Cited by Jorge L Lajara

Inspected site

ILIndustria Lechera de P.R., Inc.San Juan, United States

Inspection team

JLJorge L Lajara

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(i)(B)(3)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(i)(E)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