Stille AB Ekbacken 11
Form 483 issued September 28, 2023 · Torshalla, Sweden
- Inspection
- Sep 25 – Sep 28, 2023
- Investigator
- Kenya Destin
- Observations
- 2
- Pages
- 4
- FEI number
- 3003696170
In short: On September 28, 2023, FDA issued a Form 483 with 2 observations to Stille AB Ekbacken 11 in Torshalla, Sweden (FEI 3003696170) after an inspection that ran Sep 25 – Sep 28, 2023. The investigator was Kenya Destin. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.198(a) (1×) · 820.80(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for acceptance of incoming product have…
This inspection in context
Kenya Destin
3 documents · 2023–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmStille AB Ekbacken 11 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stille AB Ekbacken 11?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Stille AB Ekbacken 11?
Kenya Destin is named on this Form 483, for the inspection of Sep 25 – Sep 28, 2023. Each investigator has a profile showing what they cite most.
When was Stille AB Ekbacken 11 inspected by FDA?
The inspection ran Sep 25 – Sep 28, 2023, and the Form 483 is dated September 28, 2023.
How do I get the full Form 483 for Stille AB Ekbacken 11?
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.