FDA WARNING_LETTER - Rongcheng Shidao Guangxin Food Co., Ltd. - December 04, 2013
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The FDA inspected Rongcheng Shidao Guangxin Food Co., Ltd. from December 2-4, 2013, identifying serious violations of low-acid canned food (LACF) regulations (21 CFR Part 113) and misbranding issues. The firm did not respond to the initial FDA Form 483.
Key violations include: 1. **Inadequate Distribution Records (21 CFR 113.100(f)):** Shipping records identified one lot number, but products included three different lots. 2. **Container Handling and Defect Monitoring (21 CFR 113.60(d), 113.60(a)):** Field examinations revealed poorly welded/rusted side seams, damaged end seams, and dents on cans. 3. **Can Seam Teardown Records (21 CFR 113.60(a)(1)):** Records lacked corrective actions for out-of-specification body hook measurements. 4. **Scheduled Process Deficiencies (21 CFR 113.83):** The scheduled process for sardines in oil did not specify a maximum holding time for filled containers before reprocessing, and the firm did not record holding times for cans with possible seam defects.
**Misbranding Violations (Section 403(i)(2) of the Act, 21 U.S.C. 34
ID · 7976d91d-cf7f-4873-99a8-703b71ed4b17
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