Atlas

Form 483

Ronald A. Chisholm (U.S.A.), Inc. Form 483, 2020-08-19

FDA issued a Form 483 to Ronald A. Chisholm (U.S.A.), Inc. on 2020-08-19 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Ronald A. Chisholm (U.S.A.), Inc. · Linden, United States · Issued August 19, 2020

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.

19 Aug 2020
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Aldo J Milone

19 Aug 2020
21 CFR 1.505(b)

Supplier approval - document

Cited by Aldo J Milone

19 Aug 2020
21 CFR 1.506(d)(1)(i)

Verification activity assurance

Cited by Aldo J Milone

Inspected site

RARonald A. Chisholm (U.S.A.), Inc.Linden, United States

Inspection team

AJAldo J Milone

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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