|Company:||H.J. Baker & Bro., Inc.|
|Issuer:||New Orleans District Office|
|Issued:||Oct. 26, 2006||Closed:||
Department of Health and Human Services
Public Health Service
New Orleans District
October 26, 2006
WARNING LETTER NO. 2007-NOL-01
Mr. Christopher V. B. Smith
Corporate President, CEO
H. J. Baker & Bro., Inc.
228 Saugatuck Avenue
Westport, CT 06880
Dear Mr. Smith:
On June 6, 8, 12-15, and 23, 2006, a U.S. Food and Drug Administration (FDA) investigator inspected your animal feed protein supplement manufacturing facility, located at 603 Railroad Avenue, Albertville, Alabama. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589.2000 (21 CFR 589.2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation, resulting in products being manufactured and distributed by your facility because they are adulterated within the meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) and misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
Our investigation determined adulteration resulted from the failure of your firm to establish and implement measures sufficient to prevent commingling or cross-contamination. The adulterated feed was subsequently misbranded because it was not properly labeled. Specifically, we found:
Your firm failed to establish and use cleanout procedures or other means to prevent carry-over of products which contain or may contain protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B). Specifically, you failed to establish and use such measures for a screw auger installed in February 2005. This auger is used to convey both prohibited and non-prohibited material to bulk storage bins. In addition, you failed to follow the cleanout procedure your firm had developed for the receiving systems. Your feed is, therefore, adulterated under Section 402(a)(4) [21 USC 342(a)(4)] of the Act.
You failed to label all products which contained or may have contained prohibited materials with the BSE cautionary statement, "Do not feed to cattle or other ruminants," as required by 21 CFR 589.2000(e)(1)(i). Such products are misbranded under Section 403(3) [21 USC 343(a)(1)] of the Act. These misbranded products include the three Pro-Pak products mentioned below, as well as those bulk loads of individual feed ingredients processed through this common screw auger and distributed between the time it was installed in February 2005, and June 9, 2006.
This letter is not intended to serve as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
We acknowledge your June 16, 2006, voluntary recall of three products you manufactured from February 2005 to June 2006. The three products recalled were: Pro-Lak Protein Concentrate for Lactating Dairy Animals; Pro-Amino II for PreFresh and Lactating Cows; and, Pro-Pak Marine & Animal Protein Concentrate for Use in Animal Feed. Recall effectiveness checks and other measures will determine the merit of this recall . We recognize you now label all products with the required BSE cautionary statement and we also acknowledge your intent, given verbally to New Orleans District management of the FDA, to discontinue the production of supplements which do not contain prohibited materials. In your written response to this letter, please confirm in writing you have taken these steps.
You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law, including the steps we acknowledge above and any additional steps you have taken. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Kari L. Batey, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Batey at (615) 366-7808.
Carol S. Sanchez
Acting District Director
New Orleans District