FDA Intel

GLOBAL FERTILITY & GENETICS

Form 483 issued December 9, 2024 · New York, New York

Inspection
Dec 2 – Dec 9, 2024
Observations
3
Pages
4
FEI number
3013389992

In short: On December 9, 2024, FDA issued a Form 483 with 3 observations to GLOBAL FERTILITY & GENETICS in New York, New York (FEI 3013389992) after an inspection that ran Dec 2 – Dec 9, 2024. Most observations concern hCT/P.

At a glance

3 of 3 observations on this 483 concern hct/p.

HCT/P3

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 1271.50(a)

    HCT/P donors were not determined to be eligible based on the results of…

  2. 02
    21 CFR 1271.65(b)(2)

    Observation 2: scanned text, readable in the full document.

  3. 03
    21 CFR 1271.47(a)

    You did not establish and maintain procedures for screening and determining the…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The firm

GLOBAL FERTILITY & GENETICS history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 1271.50(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at GLOBAL FERTILITY & GENETICS?

FDA listed 3 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.

When was GLOBAL FERTILITY & GENETICS inspected by FDA?

The inspection ran Dec 2 – Dec 9, 2024, and the Form 483 is dated December 9, 2024.

How do I get the full Form 483 for GLOBAL FERTILITY & GENETICS?

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