Zhong Li is named in two public FDA records from 2023: a Form FDA 483 for AGC Biologics’ Bothell facility and an Establishment Inspection Report for Boehringer Ingelheim Biopharmaceuticals (China) Ltd. Those records show participation in particular inspection contexts—not a complete career history or a reliable basis for predicting how he, or any other investigator, will inspect a facility.
The practical lesson is to prepare for FDA’s inspection process, not for a named investigator. A Form 483 records significant observations, but FDA says it is not a final agency determination that a condition violates CGMP.
What the public records show about Zhong Li
AGC Biologics, Bothell
The FDA Form 483 issued February 10, 2023, for AGC Biologics in Bothell, Washington, lists Zhong Li, Ph.D., SPQA, among the inspection team. Its observations include examples involving pending documentation investigations, delayed investigation of an environmental-monitoring excursion, and corrective and preventive action in a critical filling process. These are findings recorded in that facility’s inspection; they do not establish a personal inspection style or show that Li consistently prioritizes those topics. Read the AGC Biologics Form 483.
Boehringer Ingelheim Biopharmaceuticals (China)
An FDA Establishment Inspection Report identifies Li in its account of an inspection of Boehringer Ingelheim Biopharmaceuticals (China) Ltd. from May 29 through June 9, 2023. It is another documented example of his participation, not an exhaustive list of his assignments. Read the Boehringer Ingelheim EIR.
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What a Form 483 means—and what it does not
FDA describes a Form FDA 483 as a record of significant inspectional observations. The agency’s guidance states: “A Form FDA 483 does not constitute a final agency determination of whether any condition violates CGMP.” FDA considers the observations alongside the Establishment Inspection Report, evidence collected during the inspection, and the firm’s response before deciding whether any action is appropriate. FDA’s pharmaceutical inspections and compliance guidance explains the process.
A 483 is not an all-inclusive audit report. FDA says a firm remains responsible for addressing related objectionable conditions even when they are not listed on the form. Nor does the investigator’s name on a 483 establish the facility’s final FDA classification or enforcement outcome. Classifications such as NAI, VAI, and OAI follow agency review, which considers the inspection record and the firm’s response and corrective actions. See FDA’s Form 483 FAQ and FDA’s inspection classifications.
How many inspections has Zhong Li conducted?
There is no established, complete official total in the records cited here. Commercial investigator-profile services publish different counts with different dates and counting methods:
| Source and date | Reported figures | How to interpret them |
|---|---|---|
| Redica profile, as of May 15, 2024 | 46 inspected sites in 16 countries | Commercial database count; not an official FDA census. |
| Atlas profile, last updated August 15, 2026 | 53 inspections across 51 sites; 15 Form 483 observations attributed to Li | Commercial profile count; not an official FDA census. |
The totals are not directly interchangeable: one source reports inspected sites, while the other distinguishes inspections, sites, and attributed observations. Coverage and attribution also depend on each provider’s dataset. A May 15, 2025 TechBullion article claimed 41 inspections, 38 Form 483s, and zero warning letters, but its counting method is not established here and later commercial profiles report larger totals. That dated secondary account should not be treated as a current or definitive count. Read the TechBullion article.
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Build readiness around the quality system
Prepare to explain how the firm’s controls work and to support those explanations with reliable records. The available public records do not establish investigator-specific preferences, so tailoring preparation to a named inspector would go beyond the evidence. FDA’s general inspection guidance is the sounder basis for readiness.
Make records traceable and investigations timely
The AGC 483 offers a concrete case example: its observations address documentation investigations, the timing of an environmental-monitoring investigation, and corrective and preventive action in a critical filling process. Use those examples to examine whether your own records clearly show what happened, when it was assessed, what decisions were made, and how any corrective action was followed through—not as a prediction of what another inspection will cite.
Respond to closeout observations with evidence
For a drug CGMP Form 483, FDA says firms generally have 15 business days to submit a voluntary response. A response is part of FDA’s compliance review, so it should address the observations with supporting evidence and explain relevant corrective actions. The period is general guidance, not a guarantee of a particular agency outcome. See FDA’s pharmaceutical inspections and compliance guidance.
Read the full inspection record, not just the 483
Because the 483 is not exhaustive and is not a final determination, it cannot by itself establish a facility’s overall compliance status. FDA’s review includes the EIR, collected evidence, and the firm’s response; the agency’s classification follows that review. A named investigator’s participation should not be confused with a final finding against a firm.
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