Firm Record
SCA Pharmaceuticals, LLC. findings history
79 findings from 11 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceDeviation, CAPA, and investigationEquipment and facilityLaboratory and QC controlsTraining and personnelOther quality systemLabeling and packagingQuality unit oversightDocumentation and recordsComputer system validationProcess validationComplaint and recall handlingMaterial and supplier control
Published inspection documents
2026-10-13
US FDA
15 findingsAseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Equipment and facility Your firm failed to perform adequate airflow visualization studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Your airflow visualization studies are deficient because: a. The studies do not clearly demonstrate that the airflow pattern sweeps over and away from the critical areas near and on the ISO 5 classified LAF hood work surface where aseptic operations occur. Instead, the smoke appears to arc out of the hood significantly higher than the critical area and then travel up toward the ceiling in the surrounding ISO 7 classified area. b. In your most recent airflow visualization study VAL-25-044-FR, you indicated that (b)(4) people are allowed in ISO 7 (b)(4) Room (b)(4) during aseptic operations; however, the smoke study videos provided during the FDA inspection only include a maximum of (b)(4) people, and fail to demonstrate that airflow patterns inside the ISO 5 classified critical areas are not impacted by a large number of personnel moving inside cleanroom Room (b)(4) . The FDA investigator also collected evidence indicating CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example… View the regulator's official source
2026-05-08
US FDA
3 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy and 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. View the regulator's official source
2025-12-18
US FDA
3 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. View the regulator's official source
2025-01-21
US FDA
7 findingsEquipment and facility · Aseptic processing and sterility assurance · Documentation and records · Process validation · Deviation, CAPA, and investigation Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. View the regulator's official source
2024-01-17
US FDA
7 findingsAseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Laboratory and QC controls · Labeling and packaging Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. View the regulator's official source
2024-01-17
US FDA
8 findingsAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Laboratory and QC controls Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. View the regulator's official source
2024-01-17
US FDA
10 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight Aseptic processing areas are deficient regarding the system for clean ing and disinfecting the room and equipment to produce aseptic conditions. View the regulator's official source
2024-01-17
US FDA
6 findingsTraining and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Labeling and packaging Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform. View the regulator's official source
2023-12-19
US FDA
10 findingsAseptic processing and sterility assurance · Complaint and recall handling · Equipment and facility · Quality unit oversight · Labeling and packaging · Computer system validation · Other quality system · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written. View the regulator's official source
2023-07-19
US FDA
4 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy and 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. View the regulator's official source
2020-01-07
US FDA
6 findingsTraining and personnel · Computer system validation · Documentation and records · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls Employees engaged in the processing of a drug product lack the training required to perform their assigned functions. View the regulator's official source
About this page
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
What is included. As of 2026-10-20, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
