Fresenius Kabi AG

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to follow established, approved written procedures and thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed [21 CFR 211.192]. Specifically:

Passage 2

Failure to test in-process materials for identity, strength, quality, and purity, as appropriate, and approve or reject by the quality control unit, during the production process [21 CFR 211.110(c)]. For example, your firm failed to reject lots of your bulk solutions (i.e., “mixing tanks”) and finished unsterilized units with in-process bioburden results of TNTC.

Passage 3

Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)]. For example:

Passage 4

Failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements [21 CFR 211.67(a)]. For example:

Passage 5

Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, and test procedures designed to assure that components, in-process material, and drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)]. For example:

Passage 6

Failure to adequately correct these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.