Medisca

13 FDA enforcement records linked to this company.

• recall — Class II2025-04-30

  CGMP Deviations

• recall — Class II2024-07-10

  CGMP Deviations and Presence of Particulate Matter: Glass

• recall — Class II2019-12-25

  Failed Impurities/Degradation Specifications

• 4832018-08-03

  Supervisor Training/Education/Experience

• 4832017-12-08

  Procedures not in writing, fully followed

• recall — Class II2017-09-27

  CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.

• recall — Class II2017-04-19

  cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

• recall — Class II2017-04-19

  cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

• recall — Class II2017-04-19

  cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

• recall — Class II2017-04-19

  cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

• recall — Class I2016-02-24

  Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.

• warning_letter2015-11-25

  FDA Warning Letter (drug product)

• recall — Class I2014-05-07

  Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.