Aveva Drug Delivery Systems Inc.
Form 483 issued September 1, 2023 · Miramar, Florida
- Inspection
- Aug 28 – Sep 1, 2023
- Investigator
- Steven A. Brettler
- Observations
- 2
- Pages
- 2
- FEI number
- 1000307689
In short: On September 1, 2023, FDA issued a Form 483 with 2 observations to Aveva Drug Delivery Systems Inc. in Miramar, Florida (FEI 1000307689) after an inspection that ran Aug 28 – Sep 1, 2023. The investigator was Steven A. Brettler. Most observations concern packaging & labeling and facilities & equipment; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Packaging & labeling and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.122(d) (1×) · 211.52 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Access to the storage area for labels and labeling materials is not…
- 02
Washing and toilet facilities lack…
This inspection in context
Steven A. Brettler
15 documents · 2021–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmAveva Drug Delivery Systems Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.122(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aveva Drug Delivery Systems Inc.?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and facilities & equipment. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Aveva Drug Delivery Systems Inc.?
Steven A. Brettler is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Aveva Drug Delivery Systems Inc. inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Aveva Drug Delivery Systems Inc.?
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