FDA WARNING_LETTER - M & C Catering LLC - May 08, 2013
On May 2-8, 2013, the FDA inspected M & C Catering LLC's food manufacturing facility in Summerville, SC, and found serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110, rendering products adulterated per 21 U.S.C. § 342(a)(4).
Violations included: 1. Failure to minimize microbial growth during an extended, unheated hold time for boiled peanuts (21 CFR 110.80(b)(2)). 2. Use of a wooden paddle for stirring, which is not easily cleanable (21 CFR 110.40(a)). 3. Improper storage of cleaned equipment, leading to contamination (21 CFR 110.35(e)). 4. Inadequate cleaning and sanitizing procedures; a tested sanitizer lacked sufficient chlorine (21 CFR 110.35(d)(5)). 5. Unlabeled chemical spray bottles, posing contamination risk (21 CFR 110.35(b)(2)). 6. Failure to exclude pests, with extensive rodent excreta and dead cockroaches observed in processing and adjacent areas (21 CFR 110.35(c)). 7. Insufficient space and overcrowding of equipment and non-food items, hindering sanitation and pest
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- Atlanta District Office
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ID · a3974671-6dd0-4672-8f09-e74c7e05403c
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