Biotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4
Form 483 issued September 18, 2025 · Vilnius, Lithuania
- Inspection
- Sep 12 – Sep 18, 2025
- Investigators
- Andrea Franco· Melissa Ray
- Observations
- 2
- Pages
- 2
- FEI number
- 3013580641
In short: On September 18, 2025, FDA issued a Form 483 with 2 observations to Biotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4 in Vilnius, Lithuania (FEI 3013580641) after an inspection that ran Sep 12 – Sep 18, 2025. The investigators were Andrea Franco and Melissa Ray. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used during the m@ drug substance manufacturing operations occurring in the manufacturing building@@ at your…
- 02
Preventive maintenance procedure for…
This inspection in context
Andrea Franco
5 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmBiotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Biotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4?
Andrea Franco and Melissa Ray are named on this Form 483, for the inspection of Sep 12 – Sep 18, 2025. Each investigator has a profile showing what they cite most.
When was Biotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4 inspected by FDA?
The inspection ran Sep 12 – Sep 18, 2025, and the Form 483 is dated September 18, 2025.
How do I get the full Form 483 for Biotechnologinés farmacijos centras Biotechpharma Mokslininku str. 4?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.