BSV Bioscience GmbH
Form 483 issued January 25, 2019 · Baesweiler, Germany
- Observations
- 3
- Pages
- 2
- FEI number
- 3007991333
In short: On January 25, 2019, FDA issued a Form 483 with 3 observations to BSV Bioscience GmbH in Baesweiler, Germany (FEI 3007991333). Most observations concern production and packaging & labeling.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures prescribing a system for repeating API production steps or reprocessing batches to insure that the…
- 02
Time limits are not established when appropriate for the completion af each production phase to assure…
- 03
Procedures designed to assure that correct labels, labeling, and packaging materials are used for finished API…
This inspection in context
Questions about this 483
What did FDA find at BSV Bioscience GmbH?
FDA listed 3 observations on this Form 483, mostly about production and packaging & labeling. The opening words of each observation are shown on this page.
When was BSV Bioscience GmbH inspected by FDA?
This Form 483 is dated January 25, 2019.
How do I get the full Form 483 for BSV Bioscience GmbH?
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.