Atlas

Form 483

Kabco Pharmaceuticals, Inc. Form 483, 2019-10-04

FDA issued a Form 483 to Kabco Pharmaceuticals, Inc. on 2019-10-04 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Kabco Pharmaceuticals, Inc. · Amityville, United States · Issued October 4, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

4 Oct 2019
21 CFR 111.15(b)(2)

Physical plant - repair

Cited by Meredith P Soehl

4 Oct 2019
21 CFR 111.16

Written procedures - cleaning

Cited by Meredith P Soehl

4 Oct 2019
21 CFR 111.255(b)

Batch record - complete

Cited by Meredith P Soehl

4 Oct 2019
21 CFR 111.260(m)

Batch record - performance

Cited by Meredith P Soehl

Inspected site

KPKabco Pharmaceuticals, Inc.Amityville, United States

Inspection team

MPMeredith P Soehl

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.15(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.16Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.260(m)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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