US FDA
Sentiss Pharma Pvt. Ltd.
2026-08-05
Changes to written procedures are not reviewed and approved by the quality control unit.
See every finding in this document View official sourceBy Category
US FDA Quality unit oversight findings
by this agency in this category 811 findings drawn from 686 published documents. The most recent cases are below; the full set is in search.
See all US FDA Quality unit oversight findingsCompanies with the most findings
Recent findings
US FDA
Sentiss Pharma Pvt. Ltd.
2026-08-05
The quality control unit lacks the responsibility and authority to approve and reject all components.
See every finding in this document View official source
US FDA
C.A.T. Gmbh and Co. KG
2026-08-05
The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
View official source
US FDA
Zydus Lifesciences Limited
2026-08-05
In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process.
See every finding in this document View official source
US FDA
Woodbine Products Company Inc.
2026-08-04
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishment of adequate written responsibilities and procedures applicable to the…
See every finding in this document View official source
US FDA
Baxalta US Inc.
2026-08-04
The responsibilities and procedures applicable to the quality control unit are not fully followed.
See every finding in this document View official sourceOther agencies
These findings are a record of the moment each document was published. 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 them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
