Atlas

Form 483

Naval Medical Center San Diego Mammography Form 483, 2019-11-20

FDA issued a Form 483 to Naval Medical Center San Diego Mammography on 2019-11-20 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Naval Medical Center San Diego Mammography · San Diego, United States · Issued November 20, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 Nov 2019
21 CFR 56.109(b)

Information given to subjects

Cited by Ronda R Loyd Jones, Marilyn S Babu, Mendoza O Wallace

20 Nov 2019
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Ronda R Loyd Jones, Marilyn S Babu, Mendoza O Wallace

20 Nov 2019
21 CFR 56.115(a)(3)

Records of continuing review

Cited by Ronda R Loyd Jones, Marilyn S Babu, Mendoza O Wallace

20 Nov 2019
21 CFR 56.115(a)(6)

Written procedures per 56.108(a) and (b)

Cited by Ronda R Loyd Jones, Marilyn S Babu, Mendoza O Wallace

Inspected site

NMNaval Medical Center San Diego MammographySan Diego, United States

Inspection team

RRRonda R Loyd Jones
MSMarilyn S Babu
MOMendoza O Wallace

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.109(b)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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