GC Hanford Manufacturing Company
Form 483 issued March 20, 2025 · Syracuse, New York
- Inspection
- Mar 10 – Mar 20, 2025
- Investigator
- Ifechimere I. Okafor
- Observations
- 6
- Pages
- 6
- FEI number
- 1310197
In short: On March 20, 2025, FDA issued a Form 483 with 6 observations to GC Hanford Manufacturing Company in Syracuse, New York (FEI 1310197) after an inspection that ran Mar 10 – Mar 20, 2025. The investigator was Ifechimere I. Okafor. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 03
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Ifechimere I. Okafor
5 documents · 2024–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New York.
The firmGC Hanford Manufacturing Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GC Hanford Manufacturing Company?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected GC Hanford Manufacturing Company?
Ifechimere I. Okafor is named on this Form 483, for the inspection of Mar 10 – Mar 20, 2025. Each investigator has a profile showing what they cite most.
When was GC Hanford Manufacturing Company inspected by FDA?
The inspection ran Mar 10 – Mar 20, 2025, and the Form 483 is dated March 20, 2025.
How do I get the full Form 483 for GC Hanford Manufacturing Company?
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.