Form 483

LUTIMI NR Corp. dba Pumping Out Supplements Form 483, 2026-03-13

FDA issued a Form 483 to LUTIMI NR Corp. dba Pumping Out Supplements on 2026-03-13 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

LUTIMI NR Corp. dba Pumping Out Supplements · Miramar, United States · Issued March 13, 2026

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

13 Mar 2026
21 CFR 111.103

Written procedures - establish; quality control operations

Cited by Frances M Rivera, Wilmarie Rivera-Santiago

13 Mar 2026
21 CFR 111.15(d)(1)

Animals and pests in facility

Cited by Frances M Rivera, Wilmarie Rivera-Santiago

13 Mar 2026
21 CFR 111.16

Written procedures - establish; cleaning

Cited by Frances M Rivera, Wilmarie Rivera-Santiago

13 Mar 2026
21 CFR 111.453

Written procedures - establish; holding and distribution

Cited by Frances M Rivera, Wilmarie Rivera-Santiago

13 Mar 2026
21 CFR 111.503

Written procedures - establish; returned dietary supplements

Cited by Frances M Rivera, Wilmarie Rivera-Santiago

Inspected site

Inspection team

WRWilmarie Rivera-Santiago

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.15(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.16Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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