H&P Industries, Inc.
FDA inspection history across 2 sites, 2002 to 2015
- 5
- Form 483s
- 4
- Responses
- 4
- EIRs
Every document, by year
- Form 483
- Response
- EIR
2002: one inspection report; 2003: one inspection report; 2005: one inspection report; 2006: one inspection report; 2009: one Form 483; 2010: one Form 483; 2011: four fda_correspondence, two 483 responses and two Form 483s; 2015: two 483 responses and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002–06Four inspection reports, at Hartland, Wisconsin and Mukwonago, Wisconsin.
- 2009–11Four Form 483s, four fda_correspondence and two 483 responses, at Hartland, Wisconsin.
- 2011The longest 483 on file: 46 observations over 30 pages at Hartland, Wisconsin.
- 2015Two 483 responses and one Form 483, at Hartland, Wisconsin.
Cited most
Across all H&P Industries observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance15
- 21 CFR 211.160(a)General requirements10
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products9
- 21 CFR 211.165(a)Testing and release for distribution9
- 21 CFR 211.192Production record review8
The complete H&P Industries file.
All 13 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hartland, Wisconsin
Five Form 483s, three 483 responses and three inspection reports · 2002 to 2015 · 133 observations
Latest: Form 483, Jul 23, 2015 →Mukwonago, Wisconsin
One inspection report · 2005
Latest: EIR, Aug 16, 2005 →
Also: five documents not tied to a site.
Documents
17 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-23 | 483 Form 483 | Hartland, Wisconsin | 10 | $99 |
| 2015-07-11 | Response 483 response | Hartland, Wisconsin | 21 | $199 |
| 2015-07-11 | Response 483 response | Hartland, Wisconsin | 2 | $199 |
| 2011-12-02 | fda_correspondence FDA document | — | — | — |
| 2011-11-23 | fda_correspondence FDA document | — | — | — |
| 2011-10-04 | fda_correspondence FDA document | — | — | — |
| 2011-08-19 | Response 483 response | — | — | $199 |
| 2011-06-16 | fda_correspondence FDA document | — | — | — |
| 2011-03-28 | 483 Form 483 | Hartland, Wisconsin | 10 | $99 |
| 2011-01-28 | Response 483 response | Hartland, Wisconsin | — | $199 |
| 2011-01-07 | 483 Form 483 | Hartland, Wisconsin | 46 | $99 |
| 2010-05-18 | 483 Form 483 | Hartland, Wisconsin | 23 | $99 |
| 2009-07-17 | 483 Form 483 | Hartland, Wisconsin | 21 | $99 |
| 2006-11-09 | EIR EIR | Hartland, Wisconsin | — | $550 |
| 2005-08-16 | EIR EIR | Mukwonago, Wisconsin | — | $550 |
| 2003-02-12 | EIR EIR | Hartland, Wisconsin | — | $550 |
| 2002-08-29 | EIR EIR | Hartland, Wisconsin | — | $550 |
Investigators on these documents
Sandra A. Hughes (5)Justin A. Boyd (4)Marie A. Fadden (3)Joel D. Hustedt (2)Jeffry A. Bernhardt (2)Chad E. Schmear (1)Janis R. Armendariz (1)D. Hustedt (1)
FEI number 2128643 · most recent document Jul 23, 2015
About H&P Industries, Inc.
How many FDA Form 483s has H&P Industries, Inc. received?
FDA Intel has 5 Form 483s on file for H&P Industries, Inc.; the most recent is dated Jul 23, 2015.
When was H&P Industries, Inc. last inspected by FDA?
The most recent FDA inspection document on file for H&P Industries, Inc. is a Form 483 dated Jul 23, 2015, for the site in Hartland, Wisconsin.
What did FDA cite at H&P Industries, Inc.?
The regulations cited most in the observations on file for H&P Industries, Inc. are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 15 times; 21 CFR 211.160(a) (General requirements), 10 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 9 times.