Corden Pharma Boulder, Inc.
Form 483 issued June 28, 2013 · Boulder, Colorado
- Investigators
- Elisa J. Beard· Jamie L. Dion· Kimberley Buytaert-Hoefen
- Observations
- 3
- Pages
- 3
- FEI number
- 1710165
In short: On June 28, 2013, FDA issued a Form 483 with 3 observations to Corden Pharma Boulder, Inc. in Boulder, Colorado (FEI 1710165). The investigators were Elisa J. Beard, Jamie L. Dion and Kimberley Buytaert-Hoefen. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.192 (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no documentation of the thorough review of failures to meet specifications impacting the identity…
- 02
On 6/24/13, the raw material sampling room located in the warehouse was observed in disrepair…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Elisa J. Beard
4 documents · 2010–2013
Cites 110.20(a)(1) (plant and grounds) more than any other section. Most of their documents are for sites in Colorado.
The firmCorden Pharma Boulder, 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corden Pharma Boulder, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Corden Pharma Boulder, Inc.?
Elisa J. Beard, Jamie L. Dion and Kimberley Buytaert-Hoefen are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Corden Pharma Boulder, Inc. inspected by FDA?
This Form 483 is dated June 28, 2013.
How do I get the full Form 483 for Corden Pharma Boulder, 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.