Form 483

Elaine E. Tseng, M.D. Form 483, 2022-01-07

FDA issued a Form 483 to Elaine E. Tseng, M.D. on 2022-01-07 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Elaine E. Tseng, M.D. · San Francisco, United States · Issued January 7, 2022

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

7 Jan 2022
21 CFR 812.110(b)

Investigator non-compliance with agreement/plan/regulations

Cited by Dustin P Tran, Linh Tu

Inspected site

EEElaine E. Tseng, M.D.San Francisco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.110(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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