# FDA 483 - LSNE-Leon, SLU - September 19, 2023

Source: https://www.keypedia.com/records/483/lsne-leon-slu/d446def7-619a-4220-af96-eb8e31c88f8a

> FDA 483 for LSNE-Leon, SLU on September 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LSNE-Leon, SLU
- Inspection Date: 2023-09-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: LSNE-Leon, SLU, a sterile drug manufacturer in Leon, Spain, was cited for significant deficiencies during an FDA inspection. Observations included inadequate integrity testing of RABS equipment, scientifically unjustified invalidation of OOS results and a stability chamber excursion, poor quality unit oversight of production activities, and a deficient supplier qualification program for sterile APIs. These issues indicate a lack of robust quality control and aseptic process assurance.

## Related Documents

- [483 - 2018-10-16](https://www.keypedia.com/records/483/lsne-leon-slu/d21b59cc-4bc8-490b-8720-ddf9dba3a6c5)
- [483 - 2018-10-08](https://www.keypedia.com/records/483/lsne-leon-slu/de788a02-3087-4f7b-b63f-aa7e59e16731)
- [483 - 2018-10-16](https://www.keypedia.com/records/483/lsne-leon-slu/f43f1b67-6afa-45d1-bd05-8efe1aefc3bd)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/lsne-leon-slu/44b5bd66-624e-4c64-8c14-68139ec58183

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