Form 483

Allied Pharmacy Products. Inc. Form 483, 2015-11-20

FDA issued a Form 483 to Allied Pharmacy Products. Inc. on 2015-11-20 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Allied Pharmacy Products. Inc. · Delray Beach, United States · Issued November 20, 2015

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.

20 Nov 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Ronald Ifraimov

20 Nov 2015
21 CFR 820.198(a)

Complaints

Cited by Ronald Ifraimov

20 Nov 2015
21 CFR 820.30(a)

Design control - no procedures

Cited by Ronald Ifraimov

Inspected site

APAllied Pharmacy Products. Inc.Delray Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)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