Zhejiang Hisun Pharmaceutical Co., Ltd.
Form 483 issued August 11, 2017 · Taizhou, China
- Observations
- 8
- Pages
- 5
- FEI number
- 3007719313
In short: On August 11, 2017, FDA issued a Form 483 with 8 observations to Zhejiang Hisun Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3007719313). Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
5 of 8 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (4×)
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 always include relevant metadata in order ensure…
- 02
Written procedures are deficient regarding the cleaning…
- 03
Storage conditions for samples retained for testing…
- 04
Records are not completed…
This inspection in context
Questions about this 483
What did FDA find at Zhejiang Hisun Pharmaceutical Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was Zhejiang Hisun Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated August 11, 2017.
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.