# FDA 483 - AN Co. Ltd. - May 30, 2017

Source: https://www.globalkeysolutions.net/records/483/an-co-ltd/876853c9-6350-49b2-af28-2a6691fa91d2

> FDA 483 for AN Co. Ltd. on May 30, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AN Co. Ltd.
- Inspection Date: 2017-05-30
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: AN Co. Ltd. in Yeongdong-gun, Korea, was inspected and found to have significant deficiencies across laboratory controls, production, and material systems. The inspection revealed issues including inadequate product specifications leading to recalls, lack of investigations for batch failures, insufficient stability testing, incomplete laboratory records, and unvalidated manufacturing processes. These observations indicate a systemic failure to adhere to good manufacturing practices, posing potential risks to drug product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2017-05-30](https://www.globalkeysolutions.net/records/warning_letter/an-co-ltd/eed690c0-8844-4f33-83ba-91e57475343d)

## Related Officers

- [SVP Consulting & Operations](https://www.globalkeysolutions.net/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.globalkeysolutions.net/companies/an-co-ltd/12ec535b-6af1-402d-9b38-a552efaba97e

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321