Kamada Ltd.
Form 483 issued March 2, 2023 · MP Negev
- Inspection
- Feb 22 – Mar 2, 2023
- Investigators
- Olga Simakova· Pete Amin· Prajakta Varadkar
- Observations
- 5
- Pages
- 4
- FEI number
- 1000630279
In short: On March 2, 2023, FDA issued a Form 483 with 5 observations to Kamada Ltd. in MP Negev (FEI 1000630279) after an inspection that ran Feb 22 – Mar 2, 2023. The investigators were Olga Simakova, Pete Amin and Prajakta Varadkar. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Adequate process validation for (b) (4) used during the (b) (4)…
- 02
Internal SOPs, recommendations of the equipment's manufacturer and process control procedures in execution of various production…
- 03
Facilities are not in…
- 04
During observation of aseptic filling setup procedure, the followings were noted…
This inspection in context
Olga Simakova
2 documents · 2019–2023
Cites 211.130 (packaging and labeling operations) more than any other section. Most of their documents are for sites in California.
The firmKamada Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kamada Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Kamada Ltd.?
Olga Simakova, Pete Amin and Prajakta Varadkar are named on this Form 483, for the inspection of Feb 22 – Mar 2, 2023. Each investigator has a profile showing what they cite most.
When was Kamada Ltd. inspected by FDA?
The inspection ran Feb 22 – Mar 2, 2023, and the Form 483 is dated March 2, 2023.
How do I get the full Form 483 for Kamada Ltd.?
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.