ADVANCED ACCELERATOR APPLICATIONS USA INC
Overview
ADVANCED ACCELERATOR APPLICATIONS USA INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering LUTETIUM [177 LU] TRICHLORIDE.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances ADVANCED ACCELERATOR APPLICATIONS USA INC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
ADVANCED ACCELERATOR APPLICATIONS USA INC holds 1 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- LUTETIUM [177 LU] TRICHLORIDEActive2017-05-02
- LYSINE HYDROCHLORIDE (HCI)-ARGININE HYDROCHLORIDE (HCI), 2.5%, SOLUTIONInactive2016-09-26
- KIT FOR PREPARATION OF 99M TC-RHANNEXIN V-128Inactive2015-03-10
FDA compliance signals
9 FDA enforcement records linked to this company.
- recall — Class II2024-10-09
CGMP deviations
- recall — Class III2023-08-23
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
- 4832022-11-03
Procedures not in writing, fully followed
- 4832022-11-03
Calibration/Inspection/Checking not done
- 4832022-11-03
Absence of Written Procedures
- 4832022-11-03
Investigations of discrepancies, failures
- 4832022-11-03
Procedures for sterile drug products
- recall — Class III2022-04-13
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
- recall — Class II2020-01-29
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
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