H&P Industries, Inc.
Form 483 issued July 17, 2009 · Hartland, Wisconsin
- Inspection
- Jul 15 – Jul 17, 2009
- Investigators
- Joel D. Hustedt· Marie A. Fadden· Sandra A. Hughes
- Observations
- 21
- Pages
- 6
- FEI number
- 2128643
In short: On July 17, 2009, FDA issued a Form 483 with 21 observations to H&P Industries, Inc. in Hartland, Wisconsin (FEI 2128643) after an inspection that ran Jul 15 – Jul 17, 2009. The investigators were Joel D. Hustedt, Marie A. Fadden and Sandra A. Hughes. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.67(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP…
- 03
Investigations of a failure of a batch or any of its components to meet any of…
- 04
Reprocessing was performed without the approval of…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
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 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at H&P Industries, Inc.?
FDA listed 21 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected H&P Industries, Inc.?
Joel D. Hustedt, Marie A. Fadden and Sandra A. Hughes are named on this Form 483, 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 Form 483 is dated July 17, 2009.
How do I get the full Form 483 for H&P Industries, Inc.?
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