FDA EIR - Mikart LLC - April 26, 2022

Mikart LLC, a contract pharmaceutical developer, manufacturer, and packager located in Atlanta, GA, underwent an FDA inspection from April 19 to April 26, 2022. The inspection was conducted under FDA Compliance Programs 7356.002 (Drug Manufacturing Inspections) and 7356.002B (Drug Repackagers and Relabelers), focusing on the firm's adherence to Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR 211 for finished pharmaceuticals. The scope included the Quality, Production, and Packaging and Labeling Systems, with a limited review of the Material System. The inspection specifically reviewed the firm's corrections to two observations from a previous 2019 inspection, which related to raw material receiving procedures and cGMP training, finding these corrections sufficient. While the firm was involved in a past product recall due to stability failures (exceeding microbial limits), the current inspection found no deficiencies. Consequently, no Form FDA-483, Inspectional Observations, was issued at the conclusion of the inspection. Management was reminded of their responsibility to continuously adhere to the Food, Drug, and Cosmetic Act to prevent potential enforcement actions in the future.