Firm Record
RC Outsourcing LLC findings history
72 findings from 9 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceDeviation, CAPA, and investigationLaboratory and QC controlsOther quality systemEquipment and facilityMaterial and supplier controlComplaint and recall handlingDocumentation and recordsStability and storageLabeling and packagingProcess validationTraining and personnelRegulatory reporting and change controlContamination controlQuality unit oversight
Published inspection documents
2026-04-21
US FDA
12 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Material and supplier control · Documentation and records · Deviation, CAPA, and investigation Regarding your firm’s failure to 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: a. We acknowledge the actions taken by your firm in response to your failure to adequately investigate the sterility failure of bevacizumab, lot # 20250428-488A81, and to extend the investigation to other potentially affected batches of drug product…
2025-09-22
US FDA
8 findingsDeviation, CAPA, and investigation · Documentation and records · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls Investigations of 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.
2024-12-12
US FDA
8 findingsComplaint and recall handling · Aseptic processing and sterility assurance · Process validation · Other quality system · Laboratory and QC controls · Material and supplier control Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.
2024-01-17
US FDA
7 findingsEquipment and facility · Aseptic processing and sterility assurance · Complaint and recall handling · Other quality system · Labeling and packaging Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
2024-01-17
US FDA
8 findingsEquipment and facility · Labeling and packaging · Complaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
2024-01-17
US FDA
9 findingsAseptic processing and sterility assurance · Training and personnel · Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls Test procedures relative to appropriate laboratory testing for sterility are not followed.
2023-02-03
US FDA
10 findingsAseptic processing and sterility assurance · Equipment and facility · Contamination control · Quality unit oversight · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2020-07-09
US FDA
6 findingsLaboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Stability and storage Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
2020-05-05
US FDA
4 findingsStability and storage · Laboratory and QC controls · Deviation, CAPA, and investigation There is no written testing program designed to assess the stability characteristics of drug products.
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 2026-09-03, 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.
