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FDA establishment 1216602, North Billerica, Massachusetts, United States. Part of Lantheus Medical Imaging's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 8
Official action indicated: 0
Last inspection ended: Apr 9, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.84(d)(2). Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.122(d). Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug product containers conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Dec 21, 2023
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Jan 19, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Mar 5, 2015
Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring
3 cited references
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established .
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Voluntary Action Indicated (VAI)
Jun 20, 2013
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Voluntary Action Indicated (VAI)
Jul 18, 2011
Drugs · Drug Quality Assurance
8 cited references
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.84(d)(6). Microbiological Contamination Exam Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
21 CFR 314.81(b)(1)(ii). Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
21 CFR 211.160(a). Following/documenting laboratory controls Established standards, sampling plans, test procedures, and laboratory control mechanisms are not followed.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
North Billerica, Massachusetts, United States. Part of