Hankook Cosmetics Manufacturing Co., Ltd

Form 483 issued November 21, 2024

Inspection
Nov 18 – Nov 21, 2024
Observations
5
Pages
5
FEI number
3012656014

In short: On November 21, 2024, FDA issued a Form 483 with 5 observations to Hankook Cosmetics Manufacturing Co., Ltd (FEI 3012656014) after an inspection that ran Nov 18 – Nov 21, 2024.

What FDA observed

Preview: the opening words of each observation
  1. 01

    Results of stability testing are not used…

  2. 02

    Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…

  3. 03

    The responsibilities and procedures applicable to the quality control unit are not in…

  4. 04

    Established sampling plans are not followed and documented at…

1 more observation

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 Hankook Cosmetics Manufacturing Co., Ltd?

FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.

When was Hankook Cosmetics Manufacturing Co., Ltd inspected by FDA?

The inspection ran Nov 18 – Nov 21, 2024, and the Form 483 is dated November 21, 2024.

How do I get the full Form 483 for Hankook Cosmetics Manufacturing Co., Ltd?

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