Inspections, Compliance, Enforcement, and Criminal Investigations
San-J International, Inc - Close Out Letter 9/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
September 5, 2012
Mr. Takashi Sato, President
San-J International, Inc
2880 Sprouse Drive
Richmond, VA 23231
Dear Mr. Sato:
The Food and Drug Administration recently completed a follow-up inspection on June 22, 2012 of your facility as a result of a Warning Letter issued, dated 12/27/2011. At the conclusion of your current inspection, you received a FDA-483, lnspectional Observations that addressed the following:
1. Failure to record scheduled process deviations for two sauces.
2. Failure to have your process authority evaluate the impact of reworked product.
3. Failure to document the calibration of your water activity meter.
4. Failure to maintain your facility in an appropriate sanitary condition.
We are in receipt of your response dated June 29, 2012. It appears that you addressed the observations in your response. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
CDR Rochelle B. Young,