FDA EIR - Cremica Food Industries - January 06, 2023

An FDA surveillance inspection of Cremica Food Industries, located in Phillaur, Punjab, India, took place from January 5-6, 2023. This comprehensive assessment, guided by Compliance Program Guidance Manuals for preventive controls, sanitary human food operations, and food labeling (CPGM 7303.040, 7321.005, 7303.803a), along with 21 CFR 117 Subpart C, identified several verbal observations needing corrective action. Although no formal FDA Form 483 was issued, the inspection highlighted five main issues. These included the mislabeling of products lacking egg as 'mayonnaise,' the detection of Bacillus cereus in milk solids incorporated into cold line products, the absence of on-site audits for suppliers responsible for controlling pathogen hazards in raw materials, and the lack of a dedicated label check for allergen declarations. Furthermore, the firm's acidified product, 'Veganaise,' was found to require a process filing for export to the United States, and its existing process filings for other acidified products did not adequately detail critical acidification factors. Management at Cremica Food Industries agreed to address these concerns, referencing regulatory requirements for labeling, supplier audits, and allergen controls, and acknowledging the need to update their acidified product filings. The firm plans to submit a formal response within 15 business days, understanding that unaddressed deviations could lead to regulatory actions or refusal of product entry into the U.S.