# H & P Industries, Inc. – FDA 483, Mar 28, 2011

Source: https://www.keypedia.com/records/483/h-p-industries-inc/de56d160-92a9-4185-8bfe-55ed330ac0ef

> FDA 483 for H & P Industries, Inc. on March 28, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: H & P Industries, Inc.
- Inspection Date: 2011-03-28
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: On March 21-28, 2011, the FDA inspected H & P Industries, Inc., a drug manufacturer in Hartland, WI. The inspection revealed ten observations.

**Observation 1:** Investigations into out-of-specification (OOS) results were inadequate. Examples include:
*   Microbial OOS for BZK Towelettes (lot OM172, OL276) and BZK Swabstick Solution (lot 1A21B) lacked identification of organisms or justified specification changes without proper investigation.
*   A recall of iodine prep pads due to *Elizabethkingia meningoseptica* contamination lacked an investigation into the source or impact on similar products.
*   An investigation into *B. cereus* contamination of alcohol prep pads did not assess the impact on other products using similar materials.
*   Psyllium husk products were designated for destruction due to microbial contamination from raw materials, but the investigation did not assess product already on the market.
*   Multiple OTC batches failed stability studies, with no documented investigations into the effect on products currently on the market.

**Observation 2:** Control procedures for validating manufacturing processes were not established. A 2008 validation for a high purity water system had questionable data, lacked long-term sampling, and raw microbiological data was unavailable. A revalidation stated in the protocol had not occurred.

**Observation 3:** Drains lacked

## Related Documents

- [483_RESPONSE - 2011-01-07](https://www.keypedia.com/records/483_response/h-p-industries-inc/709ed66b-1e79-4ed1-9d7a-e01214adbd0a) — date: January 7, 2011
- [483 - 2011-01-07](https://www.keypedia.com/records/483/h-p-industries-inc/44ad8331-c9d8-420c-8bbb-e71eb4f5148b) — date: January 7, 2011
- [483 - 2010-05-18](https://www.keypedia.com/records/483/h-p-industries-inc/3dcab3e6-eb93-4943-9194-a20519987c53) — date: May 18, 2010
- [EIR - 2010-04-19](https://www.keypedia.com/records/eir/h-p-industries-inc/f5e37872-639e-4da0-91db-f90cf416484e) — date: April 19, 2010
- [EIR - 2009-07-17](https://www.keypedia.com/records/eir/h-p-industries-inc/c78fc655-a0fb-4947-8bf2-12dc6db35aff) — date: July 17, 2009

## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/h-p-industries-inc/0615dbb7-164c-4d7b-8a21-86de514e9a11

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d