Zhejiang Hisun Pharmaceutical Co., Ltd.
Form 483 issued June 7, 2019 · Taizhou, China
- Inspection
- Jun 3 – Jun 7, 2019
- Observations
- 4
- Pages
- 3
- FEI number
- 3007719313
In short: On June 7, 2019, FDA issued a Form 483 with 4 observations to Zhejiang Hisun Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3007719313) after an inspection that ran Jun 3 – Jun 7, 2019. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no assurance that the equipment used in the production of firm’s active pharmaceutical ingredients…
- 02
The procedure for environmental monitoring in classified…
- 03
Validation of cleaning procedure…
- 04
Buildings used in the storage of raw materials are not maintained free…
This inspection in context
Questions about this 483
What did FDA find at Zhejiang Hisun Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment 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.
When was Zhejiang Hisun Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jun 3 – Jun 7, 2019, and the Form 483 is dated June 7, 2019.
How do I get the full Form 483 for Zhejiang Hisun 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.