# FDA 483 - Glaxo Operations UK Limited - September 06, 2019

Source: https://www.keypedia.com/records/483/glaxo-operations-uk-limited/2bef018f-36a5-45a3-a782-6a5cc2a5fe15

> FDA 483 for Glaxo Operations UK Limited on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glaxo Operations UK Limited
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Glaxo Operations UK Limited in Ware, Hertfordshire, the FDA observed a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products. Specifically, there was no sanitization of critical water supply loops feeding manufacturing and active pharmaceutical ingredient suites. This indicates a significant concern regarding microbial control within the facility's production environment.

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.keypedia.com/companies/glaxo-operations-uk-limited/203ed5e0-7ae4-490f-b37a-9293e17eae84

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