Firm Record
Central Admixture Pharmacy Services, Inc. findings history
195 findings from 23 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceEquipment and facilityDeviation, CAPA, and investigationLaboratory and QC controlsMaterial and supplier controlOther quality systemDocumentation and recordsQuality unit oversightTraining and personnelStability and storageProcess validationComputer system validationContamination controlLabeling and packagingEnvironmental monitoringRegulatory reporting and change controlData integrityValidation and qualificationComplaint and recall handlingCleaning validation
Published inspection documents
2025-12-03
US FDA
4 findingsLaboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
2025-12-01
US FDA
7 findingsDeviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight 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.
2025-06-20
US FDA
6 findingsEquipment and facility · Material and supplier control · Quality unit oversight · Other quality system There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation .
2024-08-13
US FDA
29 findingsEnvironmental monitoring · Aseptic processing and sterility assurance · Process validation · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight · Computer system validation · Equipment and facility · Data integrity · Laboratory and QC controls · Stability and storage Your firm did not adequately disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 hood.
2024-05-21
US FDA
17 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Quality unit oversight · Computer system validation · Cleaning validation · Environmental monitoring · Regulatory reporting and change control · Equipment and facility · Other quality system Your firm failed to thoroughly investigate any unexplained discrepancy or 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).
2024-05-14
US FDA
4 findingsLaboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA…
2024-01-25
US FDA
14 findingsStability and storage · Documentation and records · Equipment and facility · Complaint and recall handling · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Process validation · Quality unit oversight Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
2024-01-17
US FDA
7 findingsDeviation, CAPA, and investigation · Documentation and records · Aseptic processing and sterility assurance · Equipment and facility Written records are not made of investigations into unexplained discrepancies.
2024-01-17
US FDA
5 findingsTraining and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
2024-01-17
US FDA
3 findingsAseptic processing and sterility assurance · Training and personnel Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2024-01-17
US FDA
9 findingsAseptic processing and sterility assurance · Equipment and facility · Training and personnel · Deviation, CAPA, and investigation · Material and supplier control Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2024-01-17
US FDA
5 findingsTraining and personnel · Aseptic processing and sterility assurance · Documentation and records Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for th e duties they perform.
2024-01-17
US FDA
11 findingsOther quality system · Training and personnel · Deviation, CAPA, and investigation · Equipment and facility · Labeling and packaging · Aseptic processing and sterility assurance · Stability and storage · Documentation and records · Contamination control · Laboratory and QC controls Each lot of is not withheld from use until the lot has been sampled, tested.
2024-01-17
US FDA
3 findingsAseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
2024-01-17
US FDA
10 findingsDeviation, CAPA, and investigation · Other quality system · Material and supplier control · Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Contamination control There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed .
2024-01-17
US FDA
6 findingsQuality unit oversight · Equipment and facility · Other quality system · Material and supplier control Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
2024-01-17
US FDA
7 findingsStability and storage · Aseptic processing and sterility assurance · Material and supplier control · Training and personnel An adequate number of batches ofeach drug product are not tested to determine an appropriate expiration date.
2023-11-15
US FDA
19 findingsQuality unit oversight · Equipment and facility · Stability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance · Other quality system · Process validation · Documentation and records · Labeling and packaging · Validation and qualification · Deviation, CAPA, and investigation Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
2022-06-24
US FDA
5 findingsEquipment and facility · Material and supplier control · Aseptic processing and sterility assurance The facility is designed and operated in a way that may permit the influx of lesser quality· air into a higher quality air area.
2022-06-13
US FDA
6 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Computer system validation · Laboratory and QC controls · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
2021-09-24
US FDA
4 findingsAseptic processing and sterility assurance · Other quality system Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
2019-04-30
US FDA
8 findingsQuality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Documentation and records The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
2019-04-30
US FDA
6 findingsDocumentation and records · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls Procedures for the preparation of master production and control records are not described in a written procedure.
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.
