3M Drug Delivery Systems
Form 483 issued March 6, 2017 · Northridge, California
- Inspection
- Feb 23 – Mar 6, 2017
- Investigators
- Jeffrey P. Raimondi· Taichun Qin· Uttani T. Limchumroon
- Observations
- 1
- Pages
- 2
- FEI number
- 2010441
In short: On March 6, 2017, FDA issued a Form 483 with 1 observation to 3M Drug Delivery Systems in Northridge, California (FEI 2010441) after an inspection that ran Feb 23 – Mar 6, 2017. The investigators were Jeffrey P. Raimondi, Taichun Qin and Uttani T. Limchumroon. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firm3M Drug Delivery Systems history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 3M Drug Delivery Systems?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected 3M Drug Delivery Systems?
Jeffrey P. Raimondi, Taichun Qin and Uttani T. Limchumroon are named on this Form 483, for the inspection of Feb 23 – Mar 6, 2017. Each investigator has a profile showing what they cite most.
When was 3M Drug Delivery Systems inspected by FDA?
The inspection ran Feb 23 – Mar 6, 2017, and the Form 483 is dated March 6, 2017.
How do I get the full Form 483 for 3M Drug Delivery Systems?
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.