FDA Intel

H&P Industries, Inc.

Form 483 issued May 18, 2010 · Hartland, Wisconsin

Inspection
Apr 19 – May 18, 2010
Investigators
Joel D. Hustedt· Justin A. Boyd· Sandra A. Hughes
Observations
23
Pages
18
FEI number
2128643

In short: On May 18, 2010, FDA issued a Form 483 with 23 observations to H&P Industries, Inc. in Hartland, Wisconsin (FEI 2128643) after an inspection that ran Apr 19 – May 18, 2010. The investigators were Joel D. Hustedt, Justin A. Boyd and Sandra A. Hughes. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).

At a glance

Observations span 4 systems, led by production.

Production6
Laboratory controls6
CAPA4
Facilities & equipment3
Other4

Most cited: 21 CFR 211.113(b) (2×) · 211.100(a) (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.75(a)

    A process whose results cannot be fully verified by subsequent inspection and test has not been…

  2. 02
    21 CFR 820.80(d)

    Procedures for finished device acceptance have…

  3. 03
    21 CFR 820.198(c)

    Complaints involving the possible failure of a device and labeling to meet any of its specifications…

  4. 04
    21 CFR 803.55(a)

    A baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the…

19 more observations

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

Get the full 483

This inspection in context

The investigator

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 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 211.113(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 23 observations on this Form 483, mostly about production, laboratory controls and cAPA. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.

Who inspected H&P Industries, Inc.?

Joel D. Hustedt, Justin A. Boyd and Sandra A. Hughes are named on this Form 483, for the inspection of Apr 19 – May 18, 2010. Each investigator has a profile showing what they cite most.

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

The inspection ran Apr 19 – May 18, 2010, and the Form 483 is dated May 18, 2010.

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.

$99Get it free