BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB
Form 483 issued January 31, 2024 · Vilnius, Lithuania
- Inspection
- Jan 23 – Jan 31, 2024
- Investigators
- Gerald Feldman· Liqun Zhao· Md Rahim
- Observations
- 8
- Pages
- 4
- FEI number
- 3013580461
In short: On January 31, 2024, FDA issued a Form 483 with 8 observations to BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB in Vilnius, Lithuania (FEI 3013580461) after an inspection that ran Jan 23 – Jan 31, 2024. The investigators were Gerald Feldman, Liqun Zhao, Md Rahim and Thuy T. Nguyen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a lack of assurance that your drug substance (DS) manufacturing operations in Building. your…
- 02
The DS manufacturing facility lacks adequate space for the orderly placement of equipment and materials to…
- 03
Failure to follow your written procedures in…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Gerald Feldman
1 document · 2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Lithuania.
The firmBIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB?
Gerald Feldman, Liqun Zhao, Md Rahim and Thuy T. Nguyen are named on this Form 483, for the inspection of Jan 23 – Jan 31, 2024. Each investigator has a profile showing what they cite most.
When was BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB inspected by FDA?
The inspection ran Jan 23 – Jan 31, 2024, and the Form 483 is dated January 31, 2024.
How do I get the full Form 483 for BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB?
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.