Zhejiang Huazhou Pharmaceutical Co., Ltd.
Form 483 issued March 22, 2018 · Taizhou, China
- Inspection
- Mar 19 – Mar 22, 2018
- Investigator
- Christopher T. Middendorf
- Observations
- 8
- Pages
- 3
- FEI number
- 3012672996
In short: On March 22, 2018, FDA issued a Form 483 with 8 observations to Zhejiang Huazhou Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3012672996) after an inspection that ran Mar 19 – Mar 22, 2018. The investigator was Christopher T. Middendorf. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.194 (2×)
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 investigation of out-of-specification results…
- 02
Laboratory equipment use logs…
- 03
Appropriate controls are not present on laboratory…
- 04
You have not performed a method verification of the DMF holders Impurity method by HPLC which…
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 Huazhou Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
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 Zhejiang Huazhou Pharmaceutical Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Zhejiang Huazhou Pharmaceutical Co., Ltd.?
Christopher T. Middendorf is named on this Form 483, for the inspection of Mar 19 – Mar 22, 2018. Each investigator has a profile showing what they cite most.
When was Zhejiang Huazhou Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Mar 19 – Mar 22, 2018, and the Form 483 is dated March 22, 2018.
How do I get the full Form 483 for Zhejiang Huazhou 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.