# FDA 483 - Biotechnologinės farmacijos centras Biotechpharma UAB - January 31, 2024

Source: https://www.keypedia.com/records/483/biotechnologines-farmacijos-centras-biotechpharma-uab/5e9a5f15-ca5a-4ae6-a0ef-ed50e9de2d52

> FDA 483 for Biotechnologinės farmacijos centras Biotechpharma UAB on January 31, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biotechnologinės farmacijos centras Biotechpharma UAB
- Inspection Date: 2024-01-31
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted from January 23 to January 31, 2024, at Biotechnologinės farmacijos centras Biotechpharma UAB, a drug substance manufacturer in Vilnius, Lithuania, identified significant deficiencies. The observations, documented in an FDA Form 483, highlight several areas requiring immediate attention to ensure compliance with Good Manufacturing Practices. Key issues include a lack of assurance in manufacturing operations to prevent contamination, specifically concerning inadequate risk assessments for product cross-contamination and viral contamination when sharing equipment for different cell lines. The facility also exhibited insufficient space, leading to potential mix-ups and contamination risks during drug substance filling and material transfer. Furthermore, the inspection revealed failures in the quality control laboratory, such as deviations from written procedures for data analysis and retesting of samples without proper justification or client approval. Laboratory controls were deemed inadequate, with unverified endotoxin detection methods and a lack of thorough investigation into repeated system suitability failures. The firm also failed to effectively implement corrective and preventive actions (CAPAs) to address recurring issues like samples tested outside testing windows and lacked comprehensive product impact assessments. Additionally, procedures to prevent microbiological contamination during in-process sampling were found deficient, and environmental monitoring trends were not appropriately addressed. Equipment cleaning validations for shared assets were inadequate, lacking swab samples and data for clean hold times. Finally, the identity testing for a critical manufacturing material was not performed at established intervals. Biotechpharma UAB is required to submit a comprehensive response detailing its planned corrective actions to address these observations and ensure compliance with regulatory standards.

## Related Documents

- [483 - 2024-01-31](https://www.keypedia.com/records/483/biotechnologines-farmacijos-centras-biotechpharma-uab/108c21f7-b8e5-4268-8fa9-081413043f0f)
- [483 - 2024-01-31](https://www.keypedia.com/records/483/biotechnologines-farmacijos-centras-biotechpharma-uab/3815a647-9932-4181-8fb5-73020e9e584d)

Company: https://www.keypedia.com/companies/biotechnologines-farmacijos-centras-biotechpharma-uab/f0fd93f8-595c-4242-acd4-82803436814c

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa