Sandoz GmbH
Form 483 issued January 12, 2023 · Langkampfen, Austria
- Inspection
- Jan 9 – Jan 12, 2023
- Investigator
- Maryam Tabatabaie
- Observations
- 2
- Pages
- 4
- FEI number
- 3004828473
In short: On January 12, 2023, FDA issued a Form 483 with 2 observations to Sandoz GmbH in Langkampfen, Tyrol (FEI 3004828473) after an inspection that ran Jan 9 – Jan 12, 2023. The investigator was Maryam Tabatabaie. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmSandoz GmbH history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz GmbH?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Sandoz GmbH?
Maryam Tabatabaie is named on this Form 483, for the inspection of Jan 9 – Jan 12, 2023. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Jan 9 – Jan 12, 2023, and the Form 483 is dated January 12, 2023.
How do I get the full Form 483 for Sandoz 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.