Dark Brown Colored Liquid

Or, How Much is that Flavor Enhancer in the Window,
The One With the Waggily Salmonella Infestation?

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

Dates of Inspection: 02/12/2010 – 03/04/2010
TO: Kanaiyalal N. Patel, President
Basic Food Flavors, Inc.
North Las Vegas, NV

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Failure to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Specifically, your existing manufacturing process inside building 3950 Craig Road was not designed with the necessary steps to control microbial contamination as evidenced by the following:

(A) XXXXXX samples from one remaining finished product lot of your HVP XXXXXX were analyzed and found positive for Salmonella by your private laboratory. This was documented by Certificate of Analysis XXXXXX dated 2/19/2010.

(B) Environmental samples collected from building 3950 Craig Road found Salmonella on non-food contact surfaces near some food processing equipments throughout this facility. These findings were documented on the following private laboratory certificates of analysis provided to the FDA…

After receiving the first private laboratory analytical results (Certificate of Analysis XXXXXX dated 1/21/2010) indicating the presence of Salmonella in your facility, you continued to distribute HVP paste and powder products until 2/15/2010. Furthermore, from 1/21/2010 to 2/20/2010, you continued to manufacture HVP paste and powder products under the same processing conditions that did not minimize microbial contamination.

OBSERVATION 2
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces.

Specifically, on 2/14/2010, we observed disassembled equipment with accumulation of food debris and accumulation of dark brown colored liquid. According to your firm’s Quality Assurance/Food Technologist these surfaces have been cleaned and ready to be assembled for production. The specific food contact surfaces observed are described as follows:

1. Light brown residue was observed on the ledge close to the hinge of the east door of Large Paste Mixer.
2. Dark brown liquid was observed inside the Still XXXXXX outlet to the paste mixers. Still XXXXXX is XXXXXX holding tanks that feed in-process material into the paste mixers.
3. Brown residue and dark brown liquid were observed on the stainless steel filter screen and inside its housing. XXXXXX
4. Dark brown liquid residue was observed inside the XXXXXX conveying pipe located after the hopper outlet of Belt Dryer XXXXXX. We were informed by your firm’s Quality Assurance/Food Technologist that during production, this pipe transports XXXXXX.
5. Brown residue was observed on the inside surface of exit end of the white PVC pipe located between Mixers XXXXXX and XXXXXX inside the Grinding/Packing Room. This PVC pipe is used for diverting overflow product that can be eventually incorporated into a finished product. …

OBSERVATION 3
The plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repair. …

Moreover, we observed floor fractures and crevices along the trench drains in the Evaporator/Paste Mixers/Belt Dryers areas. Standing water was also observed in the floor areas nearby these trench drains. We observed production employee and forklift traffic in these areas and into the Grinding/Packing Room where finished powdered products are packed.

Your firm’s environmental sample results were positive for Salmonella from or near these floor areas.

OBSERVATION 4
Plumbing is not adequately installed and maintained to provide adequate floor drainage.

Specifically, during our inspection of the Evaporator/Paste Mixers/Belt Dryers areas, we observed standing, grey/black liquid in the square drain at the north end of the building, while you were manufacturing hydrolyzed vegetable protein (HVP) paste into powder products. Further, we sensed an odor in the vicinity of this drain, which collects discharge water from the east and west trench drains.

Your firm’s environmental sample results were positive for Salmonella from or near these drain areas. …

Basic Foods has, until recently, refused to respond to media inquiries about the recall of products containing its HVP flavor enhancer, which now numbers 160. But finally the company relented, telling Food Navigator-USA:

“While it is unclear whether FDA is suggesting in the Form 483 that Basic Foods knowingly shipped adulterated product, the language used by the agency and reported by the press has created that implication. We, therefore, consider it important to clarify that Basic Foods has not knowingly shipped into commerce any product the Company believed had the potential to contain Salmonella.”

So why didn’t the company just say so a few days ago when the FDA released its inspection report?

“Quite honestly, we didn’t bother answering the press because we just wanted it to go away,” Basic Foods Sales and Marketing Manager David Wood told Food Navigator. “…It’s working. It’s beginning to die down.”

The reader is invited to reach the reader’s own conclusions.