Drug factory · FDA FEI 3003719240

RedPharm Drug

6501 City West Pkwy, Eden Prairie, MN, 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.

Aug 1, 2025 inspection

• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products packed under contract by another company.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Nov 3, 2017 inspection

• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products packed under contract by another company.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Registered with FDA for: relabel; repack.