Form 483

Sciarra Laboratories, Inc. Form 483, 2018-03-29

FDA issued a Form 483 to Sciarra Laboratories, Inc. on 2018-03-29 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Sciarra Laboratories, Inc. · Hicksville, United States · Issued March 29, 2018

Overview

  • 8 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.

29 Mar 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jacqueline S Warner

29 Mar 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jacqueline S Warner

29 Mar 2018
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Jacqueline S Warner

29 Mar 2018
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Jacqueline S Warner

29 Mar 2018
21 CFR 820.80(a)

Lack of or inadequate procedures - Acceptance activities

Cited by Jacqueline S Warner

Inspected site

SLSciarra Laboratories, Inc.Hicksville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(a)Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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