Hisun Pharmaceutical (Hangzhou) Co., Ltd.
Form 483 issued July 20, 2021 · Hangzhou, China
- Inspection
- Jul 12 – Jul 20, 2021
- Investigator
- Roger F. Zabinski
- Observations
- 3
- Pages
- 4
- FEI number
- 3008481334
In short: On July 20, 2021, FDA issued a Form 483 with 3 observations to Hisun Pharmaceutical (Hangzhou) Co., Ltd. in Hangzhou, Zhejiang (FEI 3008481334) after an inspection that ran Jul 12 – Jul 20, 2021. The investigator was Roger F. Zabinski. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 2 of 3 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written methods of cleaning, sterilizing, and processing are not fully validated and followed to limit, control…
- 02
Critical process parameters are not fully monitored or…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmHisun Pharmaceutical (Hangzhou) Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hisun Pharmaceutical (Hangzhou) Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Hisun Pharmaceutical (Hangzhou) Co., Ltd.?
Roger F. Zabinski is named on this Form 483, for the inspection of Jul 12 – Jul 20, 2021. Each investigator has a profile showing what they cite most.
When was Hisun Pharmaceutical (Hangzhou) Co., Ltd. inspected by FDA?
The inspection ran Jul 12 – Jul 20, 2021, and the Form 483 is dated July 20, 2021.
How do I get the full Form 483 for Hisun Pharmaceutical (Hangzhou) 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.