Aspen Oss B.V.
Form 483 issued September 13, 2019 · Boxtel, Netherlands
- Investigator
- Guerlain Ulysse
- Observations
- 4
- Pages
- 4
- FEI number
- 3010414279
In short: On September 13, 2019, FDA issued a Form 483 with 4 observations to Aspen Oss B.V. in Boxtel, Netherlands (FEI 3010414279). The investigator was Guerlain Ulysse. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls 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
Control procedures are not established which validate the performance of manufacturing, packaging and testing processes that…
- 02
Samples taken to determine conformance to appropriate written specifications for the acceptance and identification of each…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 04
Examination of packaging and labeling materials for suitability and correctness for packaging operations is not documented…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAspen Oss B.V. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aspen Oss B.V.?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Aspen Oss B.V.?
Guerlain Ulysse is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Aspen Oss B.V. inspected by FDA?
This Form 483 is dated September 13, 2019.
How do I get the full Form 483 for Aspen Oss B.V.?
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.