# FDA 483 - YI WU JC IMPORT & EXPORT CO LTD - Unknown Date

Source: https://www.keypedia.com/records/483/yi-wu-jc-import-export-co-ltd/38278462-4c92-468b-9710-0b52ec3d6da4

> FDA 483 for YI WU JC IMPORT & EXPORT CO LTD on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: YI WU JC IMPORT & EXPORT CO LTD
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Biotechnologinės farmacijos centras Biotechpharma UAB, a drug substance manufacturer in Vilnius, Lithuania, revealed significant deficiencies across multiple areas. Observations included inadequately designed equipment leading to contamination risks, insufficient preventive maintenance procedures, and an inadequate disinfectant efficacy study. Additionally, the firm's environmental monitoring program was found to be deficient.

## Related Officers

- [Melissa D. Ray](https://www.keypedia.com/people/melissa-d-ray/d3edab82-132c-4a8f-997a-19d610a4f03a)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)

Company: https://www.keypedia.com/companies/yi-wu-jc-import-export-co-ltd/f72d7ea5-9c11-4f43-b83b-f869041db3d4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4