Spectrum Pharmaceuticals, Inc.
Form 483 issued February 12, 2020 · Boston, Massachusetts
- Inspection
- Jan 27 – Feb 12, 2020
- Observations
- 1
- Pages
- 3
- FEI number
- 3005383580
In short: On February 12, 2020, FDA issued a Form 483 with 1 observation to Spectrum Pharmaceuticals, Inc. in Boston, Massachusetts (FEI 3005383580) after an inspection that ran Jan 27 – Feb 12, 2020. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.56 (review of ongoing investigations).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.56(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An investigator who did not comply with the signed agreement and the general investigational plan was…
This inspection in context
Questions about this 483
What did FDA find at Spectrum Pharmaceuticals, Inc.?
FDA listed 1 observation 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.
When was Spectrum Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 27 – Feb 12, 2020, and the Form 483 is dated February 12, 2020.
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.