FDA 483 - H & P Industries, Inc. - March 28, 2011

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