Legacy Pharmaceutical Packaging, LLC

48 FDA enforcement records linked to this company.

• recall — Class II2024-01-03

  CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

• 4832023-06-30

  Investigations of discrepancies, failures

• 4832023-06-30

  Training , Education , Experience overall

• 4832023-06-30

  Packaging line inspection before use

• 4832023-06-30

  SOPs not followed / documented

• 4832023-06-30

  Calibration/Inspection/Checking not done

• 4832023-06-30

  Written procedures not established/followed

• warning_letter2022-10-03

  FDA Warning Letter (drug product)

• recall — Class III2020-10-07

  Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.

• recall — Class II2019-05-08

  CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

• recall — Class II2019-04-10

  CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.

• recall — Class II2019-03-27

  CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

• recall — Class II2019-03-27

  CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

• recall — Class II2019-03-27

  CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

• 4832017-05-26

  Procedure Deviations Recorded and Justified