F. Hoffmann-La Roche Ltd.
Form 483 issued August 5, 2022 · Kaiseraugst, Switzerland
- Inspection
- Jul 28 – Aug 5, 2022
- Investigator
- Michael A. Charles
- Observations
- 3
- Pages
- 3
- FEI number
- 3003973536
In short: On August 5, 2022, FDA issued a Form 483 with 3 observations to F. Hoffmann-La Roche Ltd. in Kaiseraugst, Argovia (FEI 3003973536) after an inspection that ran Jul 28 – Aug 5, 2022. The investigator was Michael A. Charles. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Manufacturer a) During aseptic…
- 03
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmF. Hoffmann-La Roche Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at F. Hoffmann-La Roche Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected F. Hoffmann-La Roche Ltd.?
Michael A. Charles is named on this Form 483, for the inspection of Jul 28 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was F. Hoffmann-La Roche Ltd. inspected by FDA?
The inspection ran Jul 28 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for F. Hoffmann-La Roche Ltd.?
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.