Zhejiang Huahai Pharmaceutical Co., Ltd.
Form 483 issued May 19, 2017 · Dugiao, China
- Inspection
- May 15 – May 19, 2017
- Investigator
- Massoud Motamed
- Observations
- 1
- Pages
- 5
- FEI number
- 3003885745
In short: On May 19, 2017, FDA issued a Form 483 with 1 observation to Zhejiang Huahai Pharmaceutical Co., Ltd. in Dugiao, Zhejiang (FEI 3003885745) after an inspection that ran May 15 – May 19, 2017. The investigator was Massoud Motamed. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not implemented over Quality Control instruments to ensure the integrity of analyticz] test…
This inspection in context
Massoud Motamed
20 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
The firmZhejiang Huahai Pharmaceutical Co., Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Huahai Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co., Ltd.?
Massoud Motamed is named on this Form 483, for the inspection of May 15 – May 19, 2017. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran May 15 – May 19, 2017, and the Form 483 is dated May 19, 2017.
How do I get the full Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd.?
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