Performance Food Group Inc – FDA Warning Letter, Aug 21, 2017

On August 15-21, 2017, the FDA inspected Performance Food Group Customized's seafood warehouse in McKinney, TX, finding serious violations of Seafood HACCP (21 CFR Part 123) and GMP (21 CFR Part 110) regulations. The firm's ready-to-eat, canned, pasteurized crabmeat was deemed adulterated.

Key violations include: 1. **Failure to take appropriate corrective action (21 CFR 123.7(a)):** The firm did not take corrective actions when pasteurized crabmeat exceeded the 40°F critical limit at receiving on July 14 and July 20, 2017, for approximately 16 and 72 hours respectively, without time/temperature assessments. The product was subsequently distributed. The firm's response of additional HACCP training was deemed inadequate as it did not include assessments of affected or other potentially impacted lots. 2. **Failure to review critical control point monitoring records (21 CFR 123.8(a)(3)):** Receiving and time/temperature indicator records for July 14 and 20, 2017, were not reviewed within one week, nor did they receive a verification review. 3. **Inadequate corrective action plan (21 CFR 123.7(b)):** The HACCP plan'