Legacy Pharmaceutical Packaging, LLC
Overview
Legacy Pharmaceutical Packaging, LLC is a private company that specializes in contract packaging for the pharmaceutical industry. They provide services such as bottling, blister packaging, compliance packaging, and other related services. The company is known for its commitment to quality and compliance with industry standards.
Therapeutic areas
FDA compliance signals
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
SOPs not followed / documented
- 4832023-06-30
Packaging line inspection before use
- 4832023-06-30
Written procedures not established/followed
- 4832023-06-30
Calibration/Inspection/Checking not done
- 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
Records reviewed annually
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