Atlas

Form 483

Life Rising Corporation Form 483, 2019-05-17

FDA issued a Form 483 to Life Rising Corporation on 2019-05-17 with 40 public-safe observations.

483· Form 483 issuedFoods & Cosmetics40 observations

Life Rising Corporation · Willowbrook, United States · Issued May 17, 2019

Overview

  • 40 public-safe observations are available for this inspection.
  • 27 structured CFR citations are represented.
  • 8 investigators are tied to this Form 483.

Inspectional observations

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

17 May 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by Dariusz Galezowski, Daniel B Arrecis, Chase S Baldwin, Jayne E Holcomb, Joshua M Adams, Nancy J Lucas, Dawnna D Brown, Peng Zhou

17 May 2019
21 CFR 111.105(i)

QC required operations components packaging labels

Cited by Dariusz Galezowski, Daniel B Arrecis, Chase S Baldwin, Jayne E Holcomb, Joshua M Adams, Nancy J Lucas, Dawnna D Brown, Peng Zhou

17 May 2019
21 CFR 111.113(b)(1)

Quality control - dietary supplement; adulteration

Cited by Dariusz Galezowski, Daniel B Arrecis, Chase S Baldwin, Jayne E Holcomb, Joshua M Adams, Nancy J Lucas, Dawnna D Brown, Peng Zhou

17 May 2019
21 CFR 111.14(b)(2)

Personnel - records - training

Cited by Dariusz Galezowski, Daniel B Arrecis, Chase S Baldwin, Jayne E Holcomb, Joshua M Adams, Nancy J Lucas, Dawnna D Brown, Peng Zhou

17 May 2019
21 CFR 111.15(k)

Sanitation supervisors - assigned

Cited by Dariusz Galezowski, Daniel B Arrecis, Chase S Baldwin, Jayne E Holcomb, Joshua M Adams, Nancy J Lucas, Dawnna D Brown, Peng Zhou

Inspected site

LRLife Rising CorporationWillowbrook, United States

Inspection team

DGDariusz Galezowski
DBDaniel B Arrecis
CSChase S Baldwin
JEJayne E Holcomb
JMJoshua M Adams
NJNancy J Lucas
DDDawnna D Brown
PZPeng Zhou

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.205(a)Cited across public-safe Form 483 observations2x
21 CFR 111.205(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.210(a)Cited across public-safe Form 483 observations2x
21 CFR 111.210(c)Cited across public-safe Form 483 observations2x
21 CFR 111.210(g)Cited across public-safe Form 483 observations2x
21 CFR 111.425Cited across public-safe Form 483 observations2x
21 CFR 111.605Cited across public-safe Form 483 observations2x
21 CFR 111.70(e)Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(2)(ii)(B)Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(2)(ii)(D)Cited across public-safe Form 483 observations2x
21 CFR 111.75(c)Cited across public-safe Form 483 observations2x
21 CFR 111.83(a)Cited across public-safe Form 483 observations2x
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.105(i)Cited across public-safe Form 483 observations1x
21 CFR 111.113(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.14(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.15(k)Cited across public-safe Form 483 observations1x
21 CFR 111.16Cited across public-safe Form 483 observations1x
21 CFR 111.210(f)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.25(c)Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.260(k)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.27(d)Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 40 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