FDA Form 483 Dendreon Corporation Morris Plains, NJ January 2010
Form 483 issued January 29, 2010
- Inspection
- Jan 25 – Jan 29, 2010
- Observations
- 3
- Pages
- 2
- FEI number
- 3005890060
In short: On January 29, 2010, FDA issued a Form 483 with 3 observations to FDA Form 483 Dendreon Corporation Morris Plains, NJ January 2010 (FEI 3005890060) after an inspection that ran Jan 25 – Jan 29, 2010. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The SOP-11020: Workstation Clearance and Change Over is deficient in that it does not require QA…
- 02
Environmental monitoring for (b)(4) conducted during the manufacturing processes is inadequate in that the (b)(4) inside…
- 03
The current cleaning procedures used in the cleanroom…
This inspection in context
Questions about this 483
What did FDA find at FDA Form 483 Dendreon Corporation Morris Plains, NJ January 2010?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was FDA Form 483 Dendreon Corporation Morris Plains, NJ January 2010 inspected by FDA?
The inspection ran Jan 25 – Jan 29, 2010, and the Form 483 is dated January 29, 2010.
How do I get the full Form 483 for FDA Form 483 Dendreon Corporation Morris Plains, NJ January 2010?
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.