Novetide Ltd.
Form 483 issued May 28, 2015 · Netanya, Israel
- Inspection
- May 25 – May 28, 2015
- Investigators
- Leonard H. Levi· Sandra A. Hughes
- Observations
- 4
- Pages
- 1
- FEI number
- 3002807897
In short: On May 28, 2015, FDA issued a Form 483 with 4 observations to Novetide Ltd. in Netanya, Israel (FEI 3002807897) after an inspection that ran May 25 – May 28, 2015. The investigators were Leonard H. Levi and Sandra A. Hughes. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to prevent unauthorized access…
- 02
Test procedures do not include sufficient detail to ensure that raw materials, intermediates and APIs conform…
- 03
Equipment cleaning for the production of iii) so not address microbiological and endotoxin…
- 04
There is no procedure describing how…
This inspection in context
Leonard H. Levi
1 document · 2015
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Israel.
The firmNovetide Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novetide Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Novetide Ltd.?
Leonard H. Levi and Sandra A. Hughes are named on this Form 483, for the inspection of May 25 – May 28, 2015. Each investigator has a profile showing what they cite most.
When was Novetide Ltd. inspected by FDA?
The inspection ran May 25 – May 28, 2015, and the Form 483 is dated May 28, 2015.
How do I get the full Form 483 for Novetide 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.