Zhejiang Huahai Pharmaceutical Co., Ltd.

Form 483 issued August 3, 2018 · Linhai, China

Inspection: Jul 23 – Aug 3, 2018
Investigators: Cheryl Clausen· Joel D. Hustedt
Observations: 11
Pages: 11
FEI number: 3003885745

In short: On August 3, 2018, FDA issued a Form 483 with 11 observations to Zhejiang Huahai Pharmaceutical Co., Ltd. in Linhai, Zhejiang (FEI 3003885745) after an inspection that ran Jul 23 – Aug 3, 2018. The investigators were Cheryl Clausen and Joel D. Hustedt. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment4

Production2

Quality system2

Laboratory controls2

Other1

Most cited: 21 CFR 211.192 (4×) · 211.67 (3×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
The change control system to evaluate all changes that may affect the production and control of…
02
21 CFR 211.100 21 CFR 211.192
Validation of production processes, cleaning procedures, analytical methods, and in-process control test procedures…
03
21 CFR 211.22 21 CFR 211.192
The system for managing quality to ensure confidence that the API will meet its intended specifications…
04
21 CFR 211.22
The quality unit does not always fulfill the responsibilities of the quality unit to release…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Cheryl Clausen

18 documents · 2016–2020

Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.

The firm

Zhejiang Huahai Pharmaceutical Co., Ltd. history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at Zhejiang Huahai Pharmaceutical Co., Ltd.?

FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and 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.?

Cheryl Clausen and Joel D. Hustedt are named on this Form 483, for the inspection of Jul 23 – Aug 3, 2018. Each investigator has a profile showing what they cite most.

When was Zhejiang Huahai Pharmaceutical Co., Ltd. inspected by FDA?

The inspection ran Jul 23 – Aug 3, 2018, and the Form 483 is dated August 3, 2018.

How do I get the full Form 483 for Zhejiang Huahai 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.