Mr. Robert Kramer
Chief Executive Officer (CEO)
Cangene BioPharma, LLC dba Emergent BioSolutions
400 Professional Drive Suite 400
Gaithersburg , MD 20879
United StatesFEI 1000512361Issued Aug 10, 2022Division of Pharmaceutical Quality Operations I
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1000512361.
Violations3
Issue DateAug 10, 2022
Product TypeDrugs
StatusClosed
Closeout LetterOct 4, 2023
Letter Details
Firm
Cangene BioPharma, LLC dba Emergent BioSolutions
Location
Mr. Robert Kramer
Chief Executive Officer (CEO)
Cangene BioPharma, LLC dba Emergent BioSolutions
400 Professional Drive Suite 400
Gaithersburg , MD 20879
United States
FEI Number
1000512361
Country
United States
Issue Date
August 10, 2022
Issuing Office
Division of Pharmaceutical Quality Operations I
Product Type
Drugs
Status
Closed
Closeout Letter
October 04, 2023
Summary
Emergent BioSolutions' Baltimore manufacturing facility failed to meet Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceutical drugs, rendering their products adulterated. FDA investigators documented significant violations including failure to adequately clean, maintain, sanitize, and sterilize equipment, as well as deficient design and control of manufacturing systems that resulted in particulate contamination (including metal particles) in sterile drug products identified through customer complaints. The facility's procedures for equipment cleaning and maintenance did not conform to regulatory standards, and the firm lacked suitable equipment controls necessary for aseptic manufacturing operations.
Cangene BioPharma, LLC dba Emergent BioSolutions FDA Warning Letter, August 10, 2022
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