On July 10, 2026, the U.S. Food and Drug Administration issued a warning letter (No. 731020) to Pratik Doshi, M.D., the clinical investigator responsible for a bioequivalence study conducted at Alembic Pharmaceuticals’ research centre in Vadodara, Gujarat, India. The letter is addressed to Dr. Doshi personally, as the named clinical investigator of record, not to Alembic Pharmaceuticals Ltd. as a corporate entity — a distinction that matters because FDA warning letters to clinical investigators are enforcement actions against the individual accountable for the conduct of the trial under 21 CFR 312.60, even where the study is run at, and tied to, a sponsor or CRO facility.
What the inspection found
The letter followed a Bioresearch Monitoring Program (BIMO) inspection of the site from March 3–7, 2025, which produced an FDA Form 483 listing inspectional observations. The warning letter states that the investigator did not comply with applicable requirements of the Federal Food, Drug, and Cosmetic Act and the human-subject-protection regulations at 21 CFR Part 50 and 21 CFR Part 312 governing the conduct of clinical investigations.
The central deficiency concerns the timing of informed consent, not the content of the consent form itself. According to the letter and subsequent trade-press reporting, the study’s informed consent form (ICF) was not obtained from at least one subject before study-related procedures began — consent was documented after, not before, procedures had already started. That sequencing is a direct violation of 21 CFR Part 50’s requirement that legally effective informed consent be obtained prior to any trial-related intervention, and it mirrors the international standard in ICH E6(R2), Section 4.8.2, which likewise requires consent before any trial-related procedure is carried out. The letter also cites language in the ICF’s “Nature and Purpose of this Study” section describing the study as research that was “not experimental in nature” — wording FDA read as potentially minimizing subjects’ understanding of what they were consenting to.
What the letter does not say
Some secondary commentary circulating after the letter’s publication has suggested the inspection also turned up problems with the site’s delegation-of-authority log. That claim does not appear in the warning letter itself or in the primary reporting on it, and CASRAI is not including it here as a confirmed finding. It appears to trace to general commentary about what BIMO inspectors typically review at bioequivalence sites, not to a documented observation in this specific letter. Readers should treat any delegation-log claim tied to this letter as unconfirmed unless FDA’s own posted letter or Form 483 is checked directly.
It is also worth noting what the company has said publicly: Alembic has stated that the observations relate specifically to the ICF used during the study and, in the company’s characterization, do not concern data integrity or restrict operations at its bioequivalence facility. The company said it is coordinating with the clinical investigator on a response to FDA within the required timeline. CASRAI has not independently verified the company’s characterization beyond what is stated in the warning letter itself, and the letter remains the primary source for the regulatory finding.
Why the timing distinction matters
Consent-timing deficiencies are a recurring BIMO finding, and they are treated differently from problems with a consent form’s content or a subject’s comprehension. A form can be well-written, IRB-approved, and fully compliant with the required-elements list at 45 CFR 46.116 and 21 CFR 50.25, and a site can still be cited if the signed, dated form was not in hand before the first trial-related procedure occurred. Sites relying on paper consent workflows are particularly exposed here because the paper trail depends entirely on staff correctly sequencing and dating the signature relative to procedure start times; eConsent systems that timestamp signature events electronically, per 21 CFR Part 11, make this specific failure mode easier to catch before it becomes an inspection finding, though they introduce their own audit-trail and validation requirements.
For research administrators and site directors, the practical takeaway is procedural rather than dramatic: the consent visit needs to be documented as strictly prior to, not concurrent with or immediately before, any protocol-mandated activity, and that sequencing needs to be independently verifiable from the source documents — not just asserted after the fact.
Frequently asked questions
Who did the FDA warning letter go to — Alembic or the investigator?
The letter, dated July 10, 2026, was addressed to Pratik Doshi, M.D., as the clinical investigator of record. It is tied to a study conducted at an Alembic Pharmaceuticals facility, but it is an enforcement action against the individual investigator, consistent with how FDA structures accountability for clinical investigators under 21 CFR 312.60.
Was this a data-integrity finding?
No. Reporting on the letter, including the company’s own public statement, describes the finding as specific to informed-consent timing under 21 CFR Part 50, not data integrity.
Did the letter cite a delegation-of-authority log problem?
Not that CASRAI can confirm from the letter or primary reporting on it. That detail appears in secondary commentary discussing BIMO inspections generally and should not be treated as a confirmed finding of this specific letter.
What regulation governs the timing of informed consent?
21 CFR Part 50 requires that legally effective informed consent be obtained before a subject is exposed to any trial-related procedure. ICH E6(R2) Section 4.8.2 states the same principle for internationally harmonized GCP.
See CASRAI’s step-by-step guide to the informed consent process, the required elements of informed consent under 45 CFR 46.116, and the informed consent checklist for researchers for how sites structure consent workflows to avoid timing gaps like the one cited here.
