# FDA 483 - Qilu Pharmaceutical Co., Ltd. (Dongjia Site) - May 24, 2024

Source: https://www.globalkeysolutions.net/records/483/qilu-pharmaceutical-co-ltd-dongjia-site/dd1a6712-e2f8-4b2f-b361-e15ff666471c

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (Dongjia Site) on May 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd. (Dongjia Site)
- Inspection Date: 2024-05-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection conducted on May 24, 2024, at Qilu Pharmaceutical Co., Ltd. (Dongjia Site) revealed significant deficiencies in its drug manufacturing operations. Issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, the observations highlight multiple instances of non-compliance with Current Good Manufacturing Practices.

Key findings include inadequate procedures to prevent microbiological contamination during sterile drug production, specifically lacking written instructions for aseptic tool positioning and operator hand sanitization within restricted access barrier systems (RABs). Equipment cleaning and maintenance procedures were found deficient, without detailed instructions for thoroughly cleaning complex production equipment like weighing balances, and failing to specify disinfection requirements for RABs after blowers are turned off. Additionally, master production and control records were incomplete, omitting critical operational instructions and documentation for disinfection activities. Finally, routine equipment qualification was deemed insufficient, as key performance parameters for manufacturing equipment were not fully verified.

Qilu Pharmaceutical is expected to implement comprehensive corrective and preventive actions to address these observations and ensure adherence to regulatory standards for drug product quality and safety.

## Related Documents

- [483 - 2024-05-24](https://www.globalkeysolutions.net/records/483/qilu-pharmaceutical-co-ltd-dongjia-site/b02ec5dd-7ed6-4bb1-93cb-44e68316c45f)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/qilu-pharmaceutical-co-ltd-dongjia-site/cc92034a-0571-4e14-b26d-03e2efd1cd97

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8