Inspections, Compliance, Enforcement, and Criminal Investigations
San-J International, Inc. 12/27/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
Baltimore, Maryland 21215
December 27, 2011
RETURN RECEIPT REQUESTED
Mr. Takashi Sato, President
San-J International, Inc.
2880 Sprouse Drive
Richmond, VA 23231
Dear Mr. Sato:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 2880 Sprouse Drive, Richmond, VA 23231 during the period of August 24-25,31,2011 and 9/1-2, 7, 2011. You are a manufacturer and co-packer of acidified soy and cooking sauces. During the inspection, the FDA investigator documented violations of Title 21, Code a/Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR 108); Part 110, Current Good Manufacturing Practice in Manufacturing (CGMP), Packing, Or Holding Human Food (21 CFR 110); and Part 114, Acidified Foods (21 CFR 114). These violations cause your food product(s) to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. §342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that the foods has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and FDA regulations through links at FDA's Internet home page at http://www.fda.gov.
We have not received a response to the FDA-483, Inspectional Observations that was issued to your firm September 7, 2011, addressing your corrective actions.
Specific violations observed during the inspection include, but are not limited, to the following:
1. You failed to follow the filed scheduled process (b)(4) on file with the FDA (b)(4) as required by 21 CFR 108.25(c)(3)(i). Review of processing records revealed processing temperatures recorded as low as (b)(4) and short processing times ranging from (b)(4) minutes.
2. You did not document the above departures from your scheduled process for in (b)(4) accordance with 21 CFR 114.89.
3. You are not examining containers prior to fill of acidified product(s) for holes or damage often enough to ensure that the container suitably protects the food from leakage or contamination as required by 21 CFR 114.80(a)(4).
4. You are not calibrating instruments used to monitor manufacturing activities such as time (chart recorder) and temperature (probe thermometer) which are used to control or prevent the growth of undesirable microorganisms in order to ensure their accuracy in accordance with the requirements of 21 CFR 110.40(t).
5. Your facility is not being maintained in an appropriate sanitary condition and good repair as required by 21 CFR 110.37 as evidenced by live and dead insect like roaches; and flaking paint directly above manufacturing areas:
This letter may not list all the deviations at your facility. You are responsible for ensuring that your manufacturing operations are in compliance with the Act; Emergency Permit Control (21 CFR 108); CGMPs for Food (21 CFR 110); and Acidified Foods (21 CFR 114). It is also your responsibility to assure all your products are in compliance with all applicable federal regulations enforced by FDA.
You should take prompt action to correct these violations noted in this letter and you should establish procedures to ensure such violations do not recur. Failure to promptly do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
You should notify this office in writing 15 working days from receipt of this letter of the specific steps you have taken to prevent recurrence. You should include in your response documentation, such as, copies of forms submitted to the FDA, and other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
If you have any questions regarding the contents of this letter, please contact CDR Rochelle B. Young at 410-779-5437.