BSV Bioscience GmbH
Form 483 issued March 11, 2016 · Baesweiler, Germany
- Inspection
- Mar 7 – Mar 11, 2016
- Investigator
- Chelsea N. Sealey
- Observations
- 4
- Pages
- 3
- FEI number
- 3007991333
In short: On March 11, 2016, FDA issued a Form 483 with 4 observations to BSV Bioscience GmbH in Baesweiler, Germany (FEI 3007991333) after an inspection that ran Mar 7 – Mar 11, 2016. The investigator was Chelsea N. Sealey. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm does not have sufficient controls in place to prevent unauthorized access or changes to…
- 02
The firm did not initiate a formal change control to evaluate changes that may affect the…
- 03
The firm does not properly document quality related complaints and follow-up…
- 04
The firm is not properly documenting and/or investigating out-of-specification results according to procedure; A. Processing of…
This inspection in context
Chelsea N. Sealey
4 documents · 2015–2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmBSV Bioscience GmbH history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BSV Bioscience GmbH?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected BSV Bioscience GmbH?
Chelsea N. Sealey is named on this Form 483, for the inspection of Mar 7 – Mar 11, 2016. Each investigator has a profile showing what they cite most.
When was BSV Bioscience GmbH inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2016, and the Form 483 is dated March 11, 2016.
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.