1Equipment and facility
Preventive maintenance procedure for equipment is inadequate.
Inspection Record
Biotechnologines farmacijos centras Biotechpharma UAB — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used during the m@ drug substance manufacturing operations occurring in the manufacturing building@@ _ at your facility are not adequately designed to ensure the prevention of contamination of equipment or product by environmental or processing conditions that would be expected to have an adverse effect on product quality.
3Environmental monitoring
Your environmental monitoring program is deficient.
4Other quality system
Your disinfectant efficacy study is inadequate.
About this record
Extracted automatically from the document US FDA published on 2026-07-13. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
