GH Genhelix S.A.
Form 483 issued January 25, 2022
- Inspection
- Jan 17 – Jan 25, 2022
- Investigators
- Revers Richard Ledwidge· Richard Ledwidge
- Observations
- 9
- Pages
- 4
- FEI number
- 3016809519
In short: On January 25, 2022, FDA issued a Form 483 with 9 observations to GH Genhelix S.A. (FEI 3016809519) after an inspection that ran Jan 17 – Jan 25, 2022. The investigators were Revers Richard Ledwidge and Richard Ledwidge.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture and processing of a drug substance shall be suitably located to…
- 02
Material Management is…
- 03
Written records of investigations into unexplained discrepancies do not always include conclusions and follow-up which are…
- 04
The responsibilities and procedures applicable to the quality control are not in…
This inspection in context
Questions about this 483
What did FDA find at GH Genhelix S.A.?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected GH Genhelix S.A.?
Revers Richard Ledwidge and Richard Ledwidge are named on this Form 483, for the inspection of Jan 17 – Jan 25, 2022. Each investigator has a profile showing what they cite most.
When was GH Genhelix S.A. inspected by FDA?
The inspection ran Jan 17 – Jan 25, 2022, and the Form 483 is dated January 25, 2022.
How do I get the full Form 483 for GH Genhelix S.A.?
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.