Henan Lihua Pharmaceutical Co Ltd

Form 483 issued December 14, 2017 · Anyang, China

Observations
2
Pages
3
FEI number
3001164052

In short: On December 14, 2017, FDA issued a Form 483 with 2 observations to Henan Lihua Pharmaceutical Co Ltd in Anyang, Henan (FEI 3001164052). Most observations concern production and laboratory controls.

At a glance

Production and laboratory controls account for 2 of 2 observations.

Production1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Manufacturing records are not…

  2. 02

    Not all QC records…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Henan Lihua Pharmaceutical Co Ltd?

FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.

When was Henan Lihua Pharmaceutical Co Ltd inspected by FDA?

This Form 483 is dated December 14, 2017.

How do I get the full Form 483 for Henan Lihua Pharmaceutical Co Ltd?

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