Taro Pharmaceutical Industries Ltd.
Form 483 issued July 11, 2019 · Haifa, Israel
- Inspection
- Jul 11, 2019
- Observations
- 1
- Pages
- 2
In short: On July 11, 2019, FDA issued a Form 483 with 1 observation to Taro Pharmaceutical Industries Ltd. in Haifa, Israel after an inspection that ran Jul 11, 2019. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Questions about this 483
What did FDA find at Taro Pharmaceutical Industries Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Taro Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Jul 11, 2019, and the Form 483 is dated July 11, 2019.
How do I get the full Form 483 for Taro Pharmaceutical Industries 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.