Spectrum Pharmaceuticals, Inc.
Form 483 issued May 27, 2016 · Boston, Massachusetts
- Inspection
- May 11 – May 27, 2016
- Investigator
- Diane C. Van Leeuwen
- Observations
- 2
- Pages
- 7
- FEI number
- 3005383580
In short: On May 27, 2016, FDA issued a Form 483 with 2 observations to Spectrum Pharmaceuticals, Inc. in Boston, Massachusetts (FEI 3005383580) after an inspection that ran May 11 – May 27, 2016. The investigator was Diane C. Van Leeuwen. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.56 (review of ongoing investigations).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.56(a) (1×) · 312.56(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to monitor the progress of an investigation…
- 02
An investigator who did not comply with the signed agreement, the general investigational plan and applicable…
This inspection in context
Diane C. Van Leeuwen
1 document · 2016
Cites 312.56(a) (review of ongoing investigations) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSpectrum Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spectrum Pharmaceuticals, Inc.?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.56 (review of ongoing investigations). The opening words of each observation are shown on this page.
Who inspected Spectrum Pharmaceuticals, Inc.?
Diane C. Van Leeuwen is named on this Form 483, for the inspection of May 11 – May 27, 2016. Each investigator has a profile showing what they cite most.
When was Spectrum Pharmaceuticals, Inc. inspected by FDA?
The inspection ran May 11 – May 27, 2016, and the Form 483 is dated May 27, 2016.
How do I get the full Form 483 for Spectrum Pharmaceuticals, 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.