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Biologics · Human Cellular, Tissue, and Gene Therapies
14 cited references
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.84(d)(2). Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
21 CFR 211.180(c). Records not made readily available to FDA Records associated with drug product control and within the retention period for such records, were not made readily available for authorized inspection.
21 CFR 211.56(c). Written procedures lacking for use of pesticides etc. Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment.
21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over air pressure, micro-organisms and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
21 CFR 211.68(b). input/output verification Input to and output from records or data are not checked for accuracy.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.42(c)(10)(vi). Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
21 CFR 211.42(c)(10)(ii). Temperature / Humidity Controls Aseptic processing areas are deficient regarding temperature and humidity controls.
21 CFR 211.42(c)(10)(i). Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that walls and ceilings are not smooth and/or hard surfaces that are easily cleanable.
Official Action Indicated (OAI)
Dec 20, 2021
Biologics · Vaccines and Allergenic ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
8 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 written.
21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.84(a). Components withheld from use pending release Each lot of drug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
21 CFR 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
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
Liberty, Missouri, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.