By Category

US FDA Computer system validation findings

by this agency in this category 144 findings drawn from 139 published documents. The most recent cases are below; the full set is in search.

See all US FDA Computer system validation findings

Companies with the most findings

Lupin Limited4Central Admixture Pharmacy Services, Inc.3Cipla Limited3Dr. Reddy's Laboratories Limited3Intas Pharmaceuticals Limited3

Recent findings

US FDA Emcure Pharmaceuticals Limited 2026-08-05

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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US FDA SNJ Labs Private Ltd. 2026-08-05

Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of data.

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US FDA Zydus Lifesciences Limited 2026-08-05

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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US FDA Strides Pharma Science Limited 2026-07-28

Your firm failed to exercise controls over computerized manufacturing equipment to ensure that only authorized personnel can create and modify recipes, that obsolete or unauthorized recipes cannot be selected for commercial manufacturing, and that accurate data input is maintained across your facility's computerized systems.

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US FDA Accura-Pac, Inc. 2026-07-16

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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US FDA Allure Labs, LLC 2026-07-15

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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Other agencies

Health CanadaUS FDA

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.