Drug factory · FDA FEI 3003294404

NuCare Pharmaceuticals,Inc.

622 W. KATELLA AVE, Orange, CA, 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.

Jan 10, 2020 inspection

• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

Mar 21, 2018 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.

Jun 14, 2010 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 to preclude mislabeling of individual containers, lots or portions of lots.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of gauges is not done at suitable intervals in accordance with an established written program.
• Returned drug products with doubt cast as to safety et. al. 21 CFR 211.204
  Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not destroyed and subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the processing and packing of a drug product lack the training required to perform their assigned functions.

Registered with FDA for: manufacture; relabel; repack.