# FDA 483 - Nectar Lifesciences Limited - March 10, 2023

Source: https://www.globalkeysolutions.net/records/483/nectar-lifesciences-limited/31ca282b-7fad-44c4-8aae-a8658c493f8a

> FDA 483 for Nectar Lifesciences Limited on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nectar Lifesciences Limited
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Nectar Lifesciences Limited identified significant deficiencies in aseptic processing, environmental monitoring, and quality control systems. The firm failed to adequately conduct aseptic process simulations and airflow studies, and did not properly record interventions during manufacturing. Repeated observations highlight a lack of timely investigations into microbial data deviations and market complaints, alongside inadequate training for visual inspectors and insufficient cleaning validation for equipment.

## Related Documents

- [UNTITLED_LETTER - 2023-09-18](https://www.globalkeysolutions.net/records/untitled_letter/nectar-lifesciences-limited/9ee14990-f59b-4d97-9d15-1be1d85ab570)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/nectar-lifesciences-limited/7b5dd8c8-0a38-4956-be6f-74871597ce80

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1