Division of Scientific Investigations

While most pharmaceutical companies are subjected to routine inspection by the FDA district offices, inspection of bioanalytical laboratories performing analyses for human BA/BE studies is generally conducted and directed by the Division of Scientific Investigations (DSI), which is within the Office of Compliance in Center of Drug Evaluation and Research of the FDA.
https://onlinelibrary.wiley.com/doi/pdf/10.1002/qaj.411

Терминология GMP
gmpua.com
https://gmpua.com › Terminology
AAPS American Association of Pharmaceutical Scientists ... CWQC Company-Wide Quality Control ... DSI Division of Scientific Investigation (FDA).

SAVA понравилась статья В США начали расследование ...
tinkoff.ru
https://www.tinkoff.ru › social › profile › SerafimaGG
По данным WSJ, расследование связано с поданной в августе в Управление по контролю качества продуктов и лекарственных препаратов (FDA) жалобой против Cassava.
https://www.tinkoff.ru/invest/social/profile/SerafimaGG/d5a7...

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Note added at 22 óra (2023-05-05 12:39:00 GMT)
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Less likely 1.

About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
https://www.news-medical.net/whitepaper/20200722/Seeing-the-...

Less likely 2.

Key-03: Inventory
Inventory refers to materials and information held for later use, controlled by inventory management processes and systems that ensure availability at minimal cost of capital. The auditor evaluates inventory structure, method of organization, degree of standardization, limits and controls, classification of items, amount of buffers and safety stocks relative to demand, replenishment triggers and process, sequence of withdrawal, vendor inventory, items in-queue versus work in process (WIP), degree of separation, obsolescence rate, the production process chain, handling and internal logistics, and how overproduction is addressed. Concepts include days of sales in inventory (DSI), flow versus batch process, pull versus push method, and economical batch sizes (EBS).
https://www.leanmap.com/audits/factory-assessment/