ZHEJIANG LEPU PHARMACEUTICAL CO., LTD.
Form 483 issued December 7, 2018 · TAIZHOU, China
- Inspection
- Dec 3 – Dec 7, 2018
- Observations
- 2
- Pages
- 2
- FEI number
- 3004414647
In short: On December 7, 2018, FDA issued a Form 483 with 2 observations to ZHEJIANG LEPU PHARMACEUTICAL CO., LTD. in TAIZHOU, Zhejiang (FEI 3004414647) after an inspection that ran Dec 3 – Dec 7, 2018. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
MATERIAL SYSTEM Drug products are not stored under appropriate conditions of temperature so that their identity…
This inspection in context
Questions about this 483
What did FDA find at ZHEJIANG LEPU PHARMACEUTICAL CO., LTD.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was ZHEJIANG LEPU PHARMACEUTICAL CO., LTD. inspected by FDA?
The inspection ran Dec 3 – Dec 7, 2018, and the Form 483 is dated December 7, 2018.
How do I get the full Form 483 for ZHEJIANG LEPU PHARMACEUTICAL CO., 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.