Teva Pharmaceutical Industries Ltd.
Form 483 issued May 23, 2023 · Kfar Saba, Israel
- Inspection
- May 14 – May 23, 2023
- Investigators
- Michael Araneta· Sean R. Marcsisin
- Observations
- 5
- Pages
- 4
- FEI number
- 3002721084
In short: On May 23, 2023, FDA issued a Form 483 with 5 observations to Teva Pharmaceutical Industries Ltd. in Kfar Saba, Israel (FEI 3002721084) after an inspection that ran May 14 – May 23, 2023. The investigators were Michael Araneta and Sean R. Marcsisin. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Michael Araneta
4 documents · 2023–2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Washington.
The firmTeva Pharmaceutical Industries Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Pharmaceutical Industries Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Teva Pharmaceutical Industries Ltd.?
Michael Araneta and Sean R. Marcsisin are named on this Form 483, for the inspection of May 14 – May 23, 2023. Each investigator has a profile showing what they cite most.
When was Teva Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran May 14 – May 23, 2023, and the Form 483 is dated May 23, 2023.
How do I get the full Form 483 for Teva Pharmaceutical Industries Ltd.?
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