H&P Industries, Inc.

Form 483 issued January 7, 2011 · Hartland, Wisconsin

Inspection: Nov 29, 2010 – Jan 7, 2011
Investigators: D. Hustedt· Justin A. Boyd· Marie A. Fadden
Observations: 46
Pages: 30
FEI number: 2128643

In short: On January 7, 2011, FDA issued a Form 483 with 46 observations to H&P Industries, Inc. in Hartland, Wisconsin (FEI 2128643) after an inspection that ran Nov 29, 2010 – Jan 7, 2011. The investigators were D. Hustedt, Justin A. Boyd, Marie A. Fadden and Sandra A. Hughes. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).

At a glance

Observations span 4 systems, led by quality system.

Quality system11

Laboratory controls10

Production10

Production & process controls5

Other10

Most cited: 21 CFR 211.192 (3×) · 211.110(a) (2×)

What FDA observed

Preview: the opening words of each observation

01
21 CFR 820.100(a)
Procedures for corrective and preventive action…
02
21 CFR 820.75(a)
A process whose results cannot be fully verified by subsequent inspection and test has not been…
03
21 CFR 820.70(e)
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
04
21 CFR 820.75(b)
Procedures for monitoring and control of process parameters for a validated process have…

42 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

D. Hustedt

1 document · 2011

Cites 211.25(a) (personnel qualifications) more than any other section. Most of their documents are for sites in Wisconsin.

The firm

H&P Industries, Inc. history

All 17 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Jan 28, 2011$199

H&P Industries, Inc. site file

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Questions about this 483

What did FDA find at H&P Industries, Inc.?

FDA listed 46 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.

Who inspected H&P Industries, Inc.?

D. Hustedt, Justin A. Boyd, Marie A. Fadden and Sandra A. Hughes are named on this Form 483, for the inspection of Nov 29, 2010 – Jan 7, 2011. Each investigator has a profile showing what they cite most.

When was H&P Industries, Inc. inspected by FDA?

The inspection ran Nov 29, 2010 – Jan 7, 2011, and the Form 483 is dated January 7, 2011.

How do I get the full Form 483 for H&P Industries, 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.