# FDA 483 - LSNE-Leon, SLU - October 16, 2018

Source: https://www.keypedia.com/records/483/lsne-leon-slu/f43f1b67-6afa-45d1-bd05-8efe1aefc3bd

> FDA 483 for LSNE-Leon, SLU on October 16, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LSNE-Leon, SLU
- Inspection Date: 2018-10-16
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document outlines six observations made during an inspection of a drug manufacturing facility. The facility's drug application stated readiness for inspection and identified functions including primary packaging and vial labeling. However, on-site observation revealed no labeling equipment and no current capability for vial labeling operations.

The labeling equipment, though present, was not qualified for commercialization of the drug product. Furthermore, the facility lacked established written procedures for handling labeling and packing operations, including controls for label issuance, receipt, identification, storage, handling, sampling, examination, and testing of labeling and packaging materials, and procedures to ensure correct label usage.

Significant data integrity issues were noted: the Certificate of Analysis (COA) from the drug application did not match raw data from analytical test records and specification sheets for multiple batches regarding related substance impurities. Original COA records for specific batches submitted in the drug application were also unavailable. Finally, there was no established written procedure for handling changes in COA versions, and controls to track change history and prevent unauthorized changes to COAs were deficient, as evidenced by multiple versions of COAs for batches lacking unique identification numbers.

## 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 - 2023-09-19](https://www.keypedia.com/records/483/lsne-leon-slu/d446def7-619a-4220-af96-eb8e31c88f8a)

## Related Officers

- [Aditi S. Thakur](https://www.keypedia.com/people/aditi-s-thakur/1c810eb2-86b0-4cae-b51d-43f3fb276ade)
- [Khan Phommasack](https://www.keypedia.com/people/khan-phommasack/44cf3cac-1886-4eb6-82cb-1717a3ff7f1d)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c