GenIbet Biopharmaceuticals, S.A.
Form 483 issued January 31, 2023
- Investigator
- Ral Miriam Ngundi
- Observations
- 4
- Pages
- 4
- FEI number
- 3011160795
In short: On January 31, 2023, FDA issued a Form 483 with 4 observations to GenIbet Biopharmaceuticals, S.A. (FEI 3011160795). The investigator was Ral Miriam Ngundi.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the) __…
- 02
Equipment cleaning processes are…
- 03
Decontamination is incomplete or not adequately demonstrated to…
- 04
Written procedures for decontamination, cleaning, and maintenance of equipment are deficient regarding sufficient details to protect…
This inspection in context
Questions about this 483
What did FDA find at GenIbet Biopharmaceuticals, S.A.?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected GenIbet Biopharmaceuticals, S.A.?
Ral Miriam Ngundi is named on this Form 483. Each investigator has a profile showing what they cite most.
When was GenIbet Biopharmaceuticals, S.A. inspected by FDA?
This Form 483 is dated January 31, 2023.
How do I get the full Form 483 for GenIbet Biopharmaceuticals, 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.