Humacyte Global, Inc
Form 483 issued April 5, 2024 · Durham, North Carolina
- Inspection
- Apr 1 – Apr 5, 2024
- Investigators
- Alifiya H. Ghadiali· Jin Sung Hong· Laura Ricles
- Observations
- 5
- Pages
- 2
- FEI number
- 3014294024
In short: On April 5, 2024, FDA issued a Form 483 with 5 observations to Humacyte Global, Inc in Durham, North Carolina (FEI 3014294024) after an inspection that ran Apr 1 – Apr 5, 2024. The investigators were Alifiya H. Ghadiali, Jin Sung Hong, Laura Ricles and Zainab Mansaray-Stonns. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Quality oversight is inadequate for…
- 03
The contract cleaning crew was not current with theil ""lb) <4> cGMP Refresher Training as required…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Alifiya H. Ghadiali
2 documents · 2024–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmHumacyte Global, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Humacyte Global, Inc?
FDA listed 5 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Humacyte Global, Inc?
Alifiya H. Ghadiali, Jin Sung Hong, Laura Ricles and Zainab Mansaray-Stonns are named on this Form 483, for the inspection of Apr 1 – Apr 5, 2024. Each investigator has a profile showing what they cite most.
When was Humacyte Global, Inc inspected by FDA?
The inspection ran Apr 1 – Apr 5, 2024, and the Form 483 is dated April 5, 2024.
How do I get the full Form 483 for Humacyte Global, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.