Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory

Form 483 issued June 18, 2015 · Xinchang, China

Observations
8
Pages
6
FEI number
3003631275

In short: On June 18, 2015, FDA issued a Form 483 with 8 observations to Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory in Xinchang, Zhejiang (FEI 3003631275). The investigators were Age Se Guang Gao and Guang Gao.

What FDA observed

Preview: the opening words of each observation
  1. 01

    Laboratory control procedures are…

  2. 02

    QC Laboratory records are…

  3. 03

    Deviations from critical control…

  4. 04

    There is no assurance that software used to control critical processing equipment is capable of meeting…

4 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory?

FDA listed 8 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory?

Age Se Guang Gao and Guang Gao are named on this Form 483. Each investigator has a profile showing what they cite most.

When was Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory inspected by FDA?

This Form 483 is dated June 18, 2015.

How do I get the full Form 483 for Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory?

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.

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