Topway Enterprises, Inc – FDA 483, Feb 8, 2019

An FDA inspection conducted at Topway Enterprises, Inc. from February 4-8, 2019, resulted in a Form 483 outlining significant observations related to Current Good Manufacturing Practices (CGMP). The manufacturer was cited for multiple deficiencies primarily concerning sanitation conditions and facility maintenance.

Investigators observed inadequate monitoring of sanitation practices, leading to widespread uncleanliness. This included residue from previous operations on stainless-steel tables, heavily scored and chipped plastic cutting surfaces holding old residue, and unclean utensils like knives, scalers, and an ice shovel. A white plastic insulated cooler was in poor condition with cracks and residue, while production room walls, the ice machine exterior, and paper towel dispensers also exhibited uncleanliness and mold-like substances. Furthermore, the firm was not routinely measuring sanitizer solution residuals, and its three-compartment sink was improperly set up without soap or sanitizer.

Additionally, sanitation control records, specifically the "SSOP PLAN," inaccurately documented satisfactory conditions, failing to reflect the actual unsanitary environment. The facility itself presented structural issues, with cracked and uneven floors in the production room and fish cooler, leading to pooling water and black residue, hindering proper cleaning. Topway Enterprises, Inc. must address these observations to ensure its operations comply with federal regulations for food manufacturing, particularly regarding sanitation and facility maintenance.