FDA 483 - BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB - January 31, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
The FDA inspected Biotechnologines farmacijos centras Biotechpharma UAB, a drug substance manufacturer in Vilnius, Lithuania, and identified significant deficiencies. Observations included inadequate contamination prevention measures, insufficient facility space, and failures to adhere to written quality control laboratory procedures. The firm also demonstrated a lack of thorough investigations for deviations, inadequate laboratory controls for endotoxin testing, and deficiencies in microbiological contamination prevention and equipment cleaning validations.
- Inspection Date
- January 31, 2024
- Product Type
- Drugs
ID · 357b3a08-b77a-4f8b-86af-c21d5d99b284