Firm Record
QuVa Pharma, Inc. findings history
70 findings from 14 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceLaboratory and QC controlsMaterial and supplier controlTraining and personnelLabeling and packagingQuality unit oversightProcess validationOther quality systemDocumentation and recordsComplaint and recall handlingDeviation, CAPA, and investigationEquipment and facilityContamination controlStability and storageComputer system validation
Published inspection documents
2026-07-01
US FDA
3 findingsDeviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance 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.
2025-05-07
US FDA
5 findingsTraining and personnel · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions.
2025-01-16
US FDA
4 findingsProcess validation · Complaint and recall handling · Quality unit oversight · Aseptic processing and sterility assurance Your fnm 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.
2024-01-17
US FDA
4 findingsAseptic processing and sterility assurance · Documentation and records Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation or the sterilization process.
2024-01-17
US FDA
5 findingsAseptic processing and sterility assurance · Documentation and records · Material and supplier control Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
2024-01-17
US FDA
4 findingsQuality unit oversight · Process validation · Aseptic processing and sterility assurance · Complaint and recall handling The quality control unit lacks authority to fully investigate en ors that have occuned.
2024-01-17
US FDA
3 findingsLabeling and packaging · Aseptic processing and sterility assurance The labels of your outsourcing facility's drug products are deficient.
2023-04-05
US FDA
3 findingsTraining and personnel · Stability and storage · Laboratory and QC controls Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
2022-12-07
US FDA
5 findingsAseptic processing and sterility assurance · Computer system validation · Process validation · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established or followed.
2022-12-07
US FDA
4 findingsLabeling and packaging · Other quality system · Aseptic processing and sterility assurance · Documentation and records The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(I0)(A).
2019-07-25
US FDA
6 findingsQuality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Complaint and recall handling The quality control unit lacks responsibi lity to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
2019-07-24
US FDA
6 findingsAseptic processing and sterility assurance · Quality unit oversight · Material and supplier control · Equipment and facility · Other quality system Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
2019-04-30
US FDA
9 findingsMaterial and supplier control · Labeling and packaging · Training and personnel · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control You compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B <Redacted B4> and 503B <Redacted B4> Specifically, you compound drug products that: a) are identical or nearly identical to an approved drug that is not on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing; or b) are not identical or nearly identical to an approved drug, but contain a bulk drug substance that is also a component of an approved drug, and for which there is no change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.
2019-04-30
US FDA
9 findingsLabeling and packaging · Laboratory and QC controls · Aseptic processing and sterility assurance · Contamination control · Material and supplier control · Training and personnel The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l0) (A).
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.
