# FDA 483 - Alcon Singapore Manufacturing Pte Ltd. - September 08, 2023

Source: https://www.keypedia.com/records/483/alcon-singapore-manufacturing-pte-ltd/48923d24-94a5-4998-af2b-ab0ce074d6a2

> FDA 483 for Alcon Singapore Manufacturing Pte Ltd. on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcon Singapore Manufacturing Pte Ltd.
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alcon Singapore Manufacturing Pte Ltd. was inspected by the FDA from September 4-8, 2023, revealing significant deficiencies in aseptic processing, environmental monitoring, laboratory controls, and complaint investigations. The observations indicate a lack of adherence to procedures designed to prevent microbiological contamination and ensure drug product quality and purity. These issues suggest a moderate to severe risk to product sterility and quality.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.keypedia.com/companies/alcon-singapore-manufacturing-pte-ltd/f10e606c-c0cf-4e91-b2ac-0aa49bf189c4

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