Diamondback Drugs of Delaware, LLC
Form 483 issued May 17, 2013 · Scottsdale, Arizona
- Inspection
- May 6 – May 17, 2013
- Investigator
- Joey V. Quitania
- Observations
- 8
- Pages
- 6
- FEI number
- 3003542383
In short: On May 17, 2013, FDA issued a Form 483 with 8 observations to Diamondback Drugs of Delaware, LLC in Scottsdale, Arizona (FEI 3003542383) after an inspection that ran May 6 – May 17, 2013. The investigator was Joey V. Quitania. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmDiamondback Drugs of Delaware, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamondback Drugs of Delaware, LLC?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Diamondback Drugs of Delaware, LLC?
Joey V. Quitania is named on this Form 483, for the inspection of May 6 – May 17, 2013. Each investigator has a profile showing what they cite most.
When was Diamondback Drugs of Delaware, LLC inspected by FDA?
The inspection ran May 6 – May 17, 2013, and the Form 483 is dated May 17, 2013.
How do I get the full Form 483 for Diamondback Drugs of Delaware, LLC?
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.