H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)

H&P INDUSTRIES FULFILLS ITS INITIAL OBLIGATIONS AND RECEIVES RETURNED BOND

H&P Industries has a recent history of receiving significant Form FDA 483s from the FDA.  The consequence of these various recalls and 483s ultimately led to a seizure of raw materials, in-process product and final product by U.S. Marshalls.  Subsequent to that H&P Industries entered into a Consent Decree from which they are now beginning to extricate themselves. 

The FDA through their Office of Regulatory Affairs has issued fourteen documents between June 16, 2011 and January 24, 2012 which relate to their satisfying an initial portion of the Consent Decree and return of the bond to the Claimants.  The Reconditioning Plan that H&P Industries has offered to the FDA consists of a two phase approach that includes:

        Phase I — Condemned Ingredient Materials Reconditioning and Destruction

        Phase II — Quality Systems Approach to Enhanced cGMP Compliance and Start-up of Manufacturing Operations

Phase I has now been completed and the FDA is eager to learn of  Phase II in which the Quality Systems will be enhanced.

H&P Industries submitted three Reconditioning Plans between June 16, 2011 and December 5, 2011.  FDA finally concurred with H&P Industries proposal in a letter dated December 20, 2011.  The bond was returned to the Claimants on January 24, 2012.

In a FDA Memorandum of Meeting with H&P Industries dated November 21, 2011, the FDA states that they believe ” Firm should consider itself a start-up company providing all details”.  The firm was also denied approval to return all QC-sampled containers based on both microbiological and cross contamination concerns.

To learn about these fourteen documents and H&P Industries progress to date, please reference the link below:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm289239.htm