Atlas

Form 483

The Center for Reproductive Endocrinology Form 483, 2013-12-13

FDA issued a Form 483 to The Center for Reproductive Endocrinology on 2013-12-13 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

The Center for Reproductive Endocrinology · Dallas, United States · Issued December 13, 2013

Overview

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

Inspectional observations

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

13 Dec 2013
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Young M Yoon, Elisa M Fleming

13 Dec 2013
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Young M Yoon, Elisa M Fleming

13 Dec 2013
21 CFR 1271.55(d)(1)(iii)

Documentation--determination, by whom, date

Cited by Young M Yoon, Elisa M Fleming

13 Dec 2013
21 CFR 1271.65(a)

Improper release prevention--storage, I.D.

Cited by Young M Yoon, Elisa M Fleming

Inspected site

TCThe Center for Reproductive EndocrinologyDallas, United States

Inspection team

YMYoung M Yoon
EMElisa M Fleming

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(1)(iii)Cited across public-safe Form 483 observations1x
21 CFR 1271.65(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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