Yabao Pharmaceutical Co., Ltd.

Form 483 issued April 20, 2022 · Beijing, China

Observations
2
Pages
3
FEI number
3009071264

In short: On April 20, 2022, FDA issued a Form 483 with 2 observations to Yabao Pharmaceutical Co., Ltd. in Beijing, China (FEI 3009071264). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

2 of 2 observations on this 483 concern laboratory controls.

Laboratory controls2

Most cited: 21 CFR 211.160 (2×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Written procedures applicable to equipment qualification…

  2. 02

    Observation 2: scanned text, readable in the full document.

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Yabao Pharmaceutical Co., Ltd.?

FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

When was Yabao Pharmaceutical Co., Ltd. inspected by FDA?

This Form 483 is dated April 20, 2022.

How do I get the full Form 483 for Yabao Pharmaceutical Co., Ltd.?

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