Atlas

Form 483

Monica M. Mita, MD, MSc, Clinical Investigator Form 483, 2016-10-24

FDA issued a Form 483 to Monica M. Mita, MD, MSc, Clinical Investigator on 2016-10-24 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Monica M. Mita, MD, MSc, Clinical Investigator · Newport Beach, United States · Issued October 24, 2016

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.

24 Oct 2016
21 CFR 312.60

FD-1572, protocol compliance

Cited by Diane C Van Leeuwen

24 Oct 2016
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Diane C Van Leeuwen

24 Oct 2016
21 CFR 50.27(b)(2)

Short form: Oral presentation/signing

Cited by Diane C Van Leeuwen

Inspected site

MMMonica M. Mita, MD, MSc, Clinical InvestigatorNewport Beach, United States

Inspection team

DCDiane C Van Leeuwen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x
21 CFR 50.27(b)(2)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 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