FDA EIR - Colonial Chemical Solutions Inc - March 06, 2018

An FDA inspection was conducted at Colonial Chemical Solutions, Inc. in Savannah, GA, on March 6, 2018. This was an initial inspection performed under the FY 2018 FSMA Non-High Risk Inspection Program, aligned with the Domestic Food Safety Program Compliance Program 7303.803. The facility primarily operates as a warehouse for cutting, filling, and storing non-food grade chemicals and additives, with management confirming no food-grade materials were stored at this specific location during the inspection; such products are handled at their corporate site. The inspection covered a facility tour and management interviews. Significantly, no objectionable conditions were identified during the visit, and consequently, no FDA-483 Inspectional Observations form was issued to the firm. There were no samples collected, nor any refusals encountered. During the close-out discussion, management reviewed the importance of having a Food Safety Preventive Controls Alliance (FSPCA) qualified individual to ensure compliance with modernized Good Manufacturing Practice (GMP) Regulations, especially if the facility's operations were to expand into food-grade materials. The firm was also advised that any future storage of food-grade products would necessitate an update to their registration. This proactive discussion aimed to prepare the company for potential future regulatory requirements related to food safety.