Aveva Drug Delivery Systems Inc.
Form 483 issued July 26, 2019 · Miramar, Florida
- Inspection
- Jul 15 – Jul 26, 2019
- Investigator
- Richard Lyght
- Observations
- 2
- Pages
- 3
- FEI number
- 1000307689
In short: On July 26, 2019, FDA issued a Form 483 with 2 observations to Aveva Drug Delivery Systems Inc. in Miramar, Florida (FEI 1000307689) after an inspection that ran Jul 15 – Jul 26, 2019. The investigator was Richard Lyght. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
This inspection in context
Richard Lyght
2 documents · 2014–2019
Cites 211.165 (testing and release for distribution) 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 211.192
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 quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Aveva Drug Delivery Systems Inc.?
Richard Lyght is named on this Form 483, for the inspection of Jul 15 – Jul 26, 2019. Each investigator has a profile showing what they cite most.
When was Aveva Drug Delivery Systems Inc. inspected by FDA?
The inspection ran Jul 15 – Jul 26, 2019, and the Form 483 is dated July 26, 2019.
How do I get the full Form 483 for Aveva Drug Delivery Systems Inc.?
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.