Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
Form 483 issued March 22, 2019 · Wenzhou, China
- Inspection
- Mar 18 – Mar 22, 2019
- Investigator
- Christopher T. Middendorf
- Observations
- 3
- Pages
- 2
- FEI number
- 3010728912
In short: On March 22, 2019, FDA issued a Form 483 with 3 observations to Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) in Wenzhou, Zhejiang (FEI 3010728912) after an inspection that ran Mar 18 – Mar 22, 2019. The investigator was Christopher T. Middendorf. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures related to the security, integrity and control of cleaning documents associated with the production of…
- 02
Procedures related to the cleaning, subsequent check of cleaning by QA and documentation of…
- 03
Training of production employees…
This inspection in context
Christopher T. Middendorf
8 documents · 2011–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.182
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)?
Christopher T. Middendorf is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
How do I get the full Form 483 for Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)?
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