# FDA 483 - Dr. J Skinclinic, Inc - March 17, 2022

Source: https://www.globalkeysolutions.net/records/483/dr-j-skinclinic-inc/bcc9abe2-bc3b-47b9-aa22-ad3be5cb4de3

> FDA 483 for Dr. J Skinclinic, Inc on March 17, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dr. J Skinclinic, Inc
- Inspection Date: 2022-03-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Dr. J Skinclinic, Inc. in Cerritos, CA, revealed significant deficiencies in their manufacturing processes for OTC drug products. The firm failed to perform identity testing for active pharmaceutical ingredients, did not maintain or make readily available critical production and distribution records, and lacked stability data to establish expiration dates. Additionally, the company's quality unit did not conduct required annual product quality reviews for several years.

## Related Officers

- [Wenzheng Zhang](https://www.globalkeysolutions.net/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Hung H. Do](https://www.globalkeysolutions.net/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.globalkeysolutions.net/companies/dr-j-skinclinic-inc/70befa74-597b-44ca-be96-5a711d42c21d

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6