Drug factory · FDA FEI 3008887707

Fresenius Kabi USA, LLC

5200 Corporate Parkway West, Wilson, NC, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jun 24, 2016 inspection

• Unlabeled filled containers controls 21 CFR 211.130(b)
  Filled drug product containers which are set aside and held in an unlabeled condition are not identified and handled to preclude mislabeling of individual containers, lots or portions of lots.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• Documentation of Batch Investigations 21 CFR 211.188(b)(12)
  The batch production and control records are deficient in that they do not include documentation of batch investigations performed.

Registered with FDA for: analysis; manufacture.