Inspections, Compliance, Enforcement, and Criminal Investigations
ASK Foods, Inc. Response Letter
May 5, 2006
Food and Drug Administration
Philadelphia District Office
900 U.S. Customhouse
2nd and Chestnut Street
Philadelphia, PA 19106
Attention : Ms. Robin M. Rivers, Paralegal Specialist
Dear Ms. Rivers:
This responds to the Warning Letter from Mr. Gardine of 28 March 2006. As you know from our discussions with you and Mr. Gardine following our receipt of the Warning Letter, we were shocked and disturbed to received such a letter several months after the primary issues had, we believed, been resolved with your agency.
For almost sixty years, ASK Foods, Inc. has been committed to the production of quality wholesome products. We are dedicated to working with FDA in resolving this matter as quickly as possible as our history has always been one of unequivocal regulatory compliance.
As your letter indicates, our firm was inspected by FDA in November. After our response of December 6, 2005, we received copies of two sets of lab results which indicated L. monocytogenes was detected in a floor drain and in precut celery. At no time did we understand your interpretation that these results implicated finished product, especially since two separate tests on the finished product had tested negative. As you were aware, the remainder of the tested ingredient lots and the entire tested finished product were destroyed on November 7, 2005.
After the FDA November inspection and following receipt of the verbal test results, the following corrective actions were immediately taken:
1. We identified raw celery as a source of potential contamination. We then began to exclusively purchase processed and sanitized celery by December 9, 2006. Additionally, we have since outsourced all of our non-fully cooked vegetables for the same reason.
2. In an effort to reduce the possibility of harborage in drains, all of the drains in ready to eat( RTE) areas were repaired and resurfaced. This construction was completed by January 14, 2006, with all drain grates being replaced with smooth stainless covers.
In addition the following GNPs were added as a precaution:
- All floor entrances into the RTE areas are intermittently sprayed with a chemical known to be an effective bactericide for the contaminant.
- Extensive scrubbing and cleanups are conducted twice per day and an intensified clean up is conducted during weekend down time. A live steam generator was purchased to augment our sanitation chemical cleanup process.
- An aggressive sentinel laboratory monitoring program on environmental and product contact surfaces has been added as well.
We believe that these measures have established control of the pathways of this ubiquitous organism. Sampling and testing performed by an independent laboratory have confirmed our success in eliminating this contaminant from our facility.
The letter also references an observation during the inspection regarding storage of raw materials. As the inspector was made aware of during the inspection, all ingredients allegedly involved were destroyed on the spot, and employee were immediately counseled to make certain that all GMPs were followed and storage bins covered as required.
Third the letter indicates that we would reassess our Seafood HACCP plan, but that we had not yet provided a FDA with a copy of the reassessed plan. The plan was complete and on file by the date we promised, February 1, 2006. At no time during the November inspection or afterwards did anyone from FDA indicate that they wanted a copy of the reassessed plan. The first indication that we had that FDA apparently wished to receive a copy was in the March 28 letter. We have since forwarded a copy of the reassessed plan to you.
We trust that the corrective actions enumerated address all of your concerns. If, for any reason we have not, we would very much appreciate it if you would let us know, preferably by telephone, so that we can address them immediately. Should you have any further questions, please contact me directly.
ASK Foods, Inc.