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Form 483

Sciarra Laboratories, Inc. Form 483, 2011-06-03

FDA issued a Form 483 to Sciarra Laboratories, Inc. on 2011-06-03 with 2 public-safe observations.

483· Form 483 issued2 observations

Sciarra Laboratories, Inc. · Hicksville, United States · Issued June 3, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

3 Jun 2011
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Robert C Steyert

3 Jun 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Robert C Steyert

Inspected site

SLSciarra Laboratories, Inc.Hicksville, United States

Inspection team

RCRobert C Steyert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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