Atlas

Form 483

Palo Alto Medical Foundation Reproductive Endocrinology and Infertility Form 483, 2017-08-17

FDA issued a Form 483 to Palo Alto Medical Foundation Reproductive Endocrinology and Infertility on 2017-08-17 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Palo Alto Medical Foundation Reproductive Endocrinology and Infertility · San Jose, United States · Issued August 17, 2017

Overview

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

Inspectional observations

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

17 Aug 2017
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Amanda B Athey

17 Aug 2017
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Amanda B Athey

Inspected site

PAPalo Alto Medical Foundation Reproductive Endocrinology and InfertilitySan Jose, United States

Inspection team

ABAmanda B Athey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

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