Hisun Pharmaceutical (Hangzhou) Co., Ltd.
Form 483 issued October 27, 2016 · Hangzhou, China
- Inspection
- Oct 17 – Oct 27, 2016
- Investigators
- Justin A. Boyd· Sandra A. Hughes
- Observations
- 12
- Pages
- 10
- FEI number
- 3008481334
In short: On October 27, 2016, FDA issued a Form 483 with 12 observations to Hisun Pharmaceutical (Hangzhou) Co., Ltd. in Hangzhou, Zhejiang (FEI 3008481334) after an inspection that ran Oct 17 – Oct 27, 2016. The investigators were Justin A. Boyd and Sandra A. Hughes. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.194 (2×) · 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
Laboratory records do not include complete data derived from all tests necessary…
- 02
Written procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.194
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 12 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Hisun Pharmaceutical (Hangzhou) Co., Ltd.?
Justin A. Boyd and Sandra A. Hughes are named on this Form 483, for the inspection of Oct 17 – Oct 27, 2016. Each investigator has a profile showing what they cite most.
When was Hisun Pharmaceutical (Hangzhou) Co., Ltd. inspected by FDA?
The inspection ran Oct 17 – Oct 27, 2016, and the Form 483 is dated October 27, 2016.
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.