| Feb 5, 2026 | Biologics · Blood and Blood Products | 9 cited references- 21 CFR 211.65(a). Equipment construction - reactive surfaces Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
- 21 CFR 211.42(c)(5). Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
- 21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the processing of a drug product are not maintained in a good state of repair.
- 21 CFR 211.180(e)(1). Representative Number of Batches for Annual Review The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of approved and rejected batches.
- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
- 21 CFR 211.160(a). Following/documenting laboratory controls Established test procedures and laboratory control mechanisms are not followed.
- 21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to fully investigate errors that have occurred.
- 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate 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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
| Voluntary Action Indicated (VAI) |
| Sep 18, 2024 | Biologics · Blood and Blood Products | 7 cited references- 21 CFR 211.52. Washing and toilet facilities are deficient Washing and toilet facilities lack hot and cold water.
- 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 211.58. Buildings not maintained in good state of repair Buildings used in the of a drug product are not maintained in a good state of repair.
- 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 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
- 21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
- 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 in-process materials conform to appropriate standards of identity, strength, quality and purity.
| Voluntary Action Indicated (VAI) |
| Sep 24, 2022 | Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products | 9 cited references- 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 211.63. 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.
- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- 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 conform to appropriate standards of identity, strength, quality and purity.
- 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 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
- 21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to fully investigate errors that have occurred.
- 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- 21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
| Official Action Indicated (OAI) |
| Sep 24, 2021 | Biologics · Blood and Blood ProductsDrugs · Drug Quality Assurance | 4 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 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
| Official Action Indicated (OAI) |
| Sep 26, 2019 | Biologics · Blood and Blood Products | 6 cited references- 21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
- 21 CFR 211.84(d)(6). Objectionable microbiological contamination Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
- 21 CFR 211.105(a). Identification of containers, lines, equipment All compounding and storage containers used during the production of a batch of drug product is not properly identified at all times to indicate contents.
- 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 cleaning and maintenance.
- 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 211.194(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.
| Official Action Indicated (OAI) |
| Aug 22, 2017 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | 4 cited references- 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 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
- 21 CFR 314.81(b)(1)(ii). Failure to meet specifications An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
- 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.
| No Action Indicated (NAI) |
| Mar 25, 2015 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | 2 cited references- 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 211.67(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.
| No Action Indicated (NAI) |
| Feb 21, 2014 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Apr 25, 2013 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | 7 cited references- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
- 21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- 21 CFR 314.81(b)(1)(ii). Failure to meet specifications An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
- 21 CFR 211.130. Procedures are written, and followed Procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products are not written and followed.
- 21 CFR 211.198(a). Complaints reviewed by Quality Control Unit Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications.
| Official Action Indicated (OAI) |
| Feb 24, 2012 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | 3 cited references- 21 CFR 314.81(b)(1)(i). Mix-up An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be mistaken for another article.
- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- 21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
| Voluntary Action Indicated (VAI) |
| Mar 23, 2010 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | 3 cited references- 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
- 21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
| Voluntary Action Indicated (VAI) |
| Feb 2, 2009 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices; Devices · Postmarket Assurance: Devices | None posted | Official Action Indicated (OAI) |
Maricao, Puerto Rico, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.