GC Hanford Manufacturing Company
Form 483 issued June 17, 2022 · Syracuse, New York
- Inspection
- Jun 13 – Jun 17, 2022
- Observations
- 3
- Pages
- 4
- FEI number
- 1310197
In short: On June 17, 2022, FDA issued a Form 483 with 3 observations to GC Hanford Manufacturing Company in Syracuse, New York (FEI 1310197) after an inspection that ran Jun 13 – Jun 17, 2022. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Questions about this 483
What did FDA find at GC Hanford Manufacturing Company?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
When was GC Hanford Manufacturing Company inspected by FDA?
The inspection ran Jun 13 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
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.