H&P Industries, Inc.
483 response sent July 11, 2015 · Hartland, Wisconsin
- Inspection
- Jul 15 – Jul 17, 2009
- Investigator
- Marie A. Fadden
- Observations
- 21
- Pages
- 9
- FEI number
- 2128643
In short: This is H&P Industries, Inc.'s written response to FDA, dated July 11, 2015, for its site in Hartland, Wisconsin (FEI 2128643). It sets out the corrective actions the firm committed to.
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.67(b) (2×)
What the firm responded to
Preview: the opening words of each observation- 01
: The responsibilities and procedures applicable to the quality control unit are not in writing…
- 02
: OMP training is not conducted with sufficient frequency that employees remain familiar with the cOMP…
- 03
: Investigations ofa failure of a batch or any of its components to meet any of…
- 04
: Reprocessing was performed without the approval of…
17 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full responseThis inspection in context
Marie A. Fadden
8 documents · 2004–2015
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Wisconsin.
The firmH&P Industries, Inc. history
All 17 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this response
Who inspected H&P Industries, Inc.?
Marie A. Fadden is named on this 483 response, for the inspection of Jul 15 – Jul 17, 2009. Each investigator has a profile showing what they cite most.
When was H&P Industries, Inc. inspected by FDA?
The inspection ran Jul 15 – Jul 17, 2009, and the 483 response is dated July 11, 2015.
How do I get the full 483 response for H&P Industries, Inc.?
Download the original PDF from FDA Intel for $199, with no subscription. You also get an invoice PDF with the order.