FDA Intel

H&P Industries, Inc.

Form 483 issued March 28, 2011 · Hartland, Wisconsin

Inspection
Mar 21 – Mar 28, 2011
Investigators
Justin A. Boyd· Sandra A. Hughes
Observations
10
Pages
5
FEI number
2128643

In short: On March 28, 2011, FDA issued a Form 483 with 10 observations to H&P Industries, Inc. in Hartland, Wisconsin (FEI 2128643) after an inspection that ran Mar 21 – Mar 28, 2011. The investigators were Justin A. Boyd and Sandra A. Hughes. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

7 of 10 observations on this 483 concern facilities & equipment.

Facilities & equipment7
Quality system1
Production1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.192

    Investigations of a failure of a batch or any of its components to meet any of…

  2. 02
    21 CFR 211.110(a)

    Control procedures are not established which validate the performance of those manufacturing processes that may be…

  3. 03
    21 CFR 211.48(b)

    Drains are not provided with an air break or other mechanical device to prevent back-siphonage where…

  4. 04
    21 CFR 211.67(b)

    Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…

6 more observations

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

Get the full 483

This inspection in context

The investigator

Justin A. Boyd

61 documents · 2010–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.

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.

Questions about this 483

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

FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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.?

Justin A. Boyd and Sandra A. Hughes are named on this Form 483, for the inspection of Mar 21 – Mar 28, 2011. Each investigator has a profile showing what they cite most.

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

The inspection ran Mar 21 – Mar 28, 2011, and the Form 483 is dated March 28, 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.

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