Zenzi Pharmaceutical Industries Private Limited, a contract manufacturer located in Kudavali, Thane district, Maharashtra, India, is now carrying enforcement findings from two independent regulatory systems against the same physical site. The U.S. Food and Drug Administration (FDA) issued Warning Letter 320-25-45 (MARCS-CMS 701130) to the firm’s Managing Director on February 13, 2025, following Zenzi’s failure to respond adequately to records requests issued under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. FDA had already placed all drug products manufactured at the site on Import Alert 66-79 the day before, February 12, 2025. Roughly fifteen months later, on May 5, 2026, the Malta Medicines Authority — acting as the EU competent authority within the European Medicines Agency (EMA) EudraGMDP network — issued GMP non-compliance record MT/002NCR/2026 for the identical facility, following an inspection that concluded March 31, 2026. Two regulators, operating under entirely separate legal frameworks and answering to different constituencies, reached adverse findings about the same site without any apparent coordination between them. For a global CMC or supply chain executive, that is the headline before any deficiency detail is even read: independent confirmation, from two continents, that this site’s quality system cannot currently be trusted at face value.
FDA’s action did not originate from an on-site inspection identifying a specific manufacturing defect. It originated from a refusal to produce records. FDA requested documentation under Section 704(a)(4) three times — October 29, 2024, November 7, 2024, and November 15, 2024 — seeking records tied to a specific injectable product that a Zenzi customer’s own contract manufacturing agreement identified as being produced at this site. Zenzi’s Vice President of Quality responded once, denying that the firm supplied the product under the customer’s label, a denial FDA states directly contradicts records the customer separately provided, including a registration file, certificate of analysis, and batch production record. Refusing to permit access to records required under Section 704(a) is a prohibited act under Section 301(e) of the FD&C Act, distinct from and in some respects more serious than a routine documentation observation, because it removes the agency’s ability to evaluate the underlying manufacturing at all. As FDA states in the letter, the agency was left with no indication of the level of quality assurance for drugs listed as manufactured at the facility — a finding not about a failed batch, but about an inability to verify anything about how product at this site is actually made.
The EMA/Malta record is, by comparison, thin on public narrative. EudraGMDP’s public interface discloses only structured facts for this listing: report number, site identity, inspection end date, and issue date. Unlike the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) public non-compliance statements, which typically publish a detailed nature-of-non-compliance narrative describing specific deficiencies observed during inspection, the EudraGMDP network does not uniformly publish the underlying deficiency classification or specific observations behind every listed record — a disclosure gap that is itself part of a broader divergence in transparency practice across EU member-state competent authorities this quarter. What is confirmed is that Malta’s competent authority found the site non-compliant with EU GMP requirements roughly a year after FDA’s Import Alert took effect, following an inspection concluded in March 2026. What is not confirmed, and should not be assumed, is whether the EU finding addresses the same product line, the same records gap, or an unrelated deficiency category entirely; XGene’s review of both public records found no narrative basis for asserting the two findings share a root cause, only that they share a site.
Where the two actions converge is instructive. Both regulators, working from separate legal authorities and separate inspection triggers, arrived at adverse findings against the identical manufacturing site. Neither action appears to depend on the other; there is no indication that Mutual Recognition Agreement information-sharing between FDA and the EU accelerated or informed the Malta finding, since this is a third-country site outside the direct EU/US territorial scope that MRA reciprocal-reliance arrangements typically cover. That independence is precisely what makes the convergence meaningful: it suggests the underlying quality-system weakness at this site is real and persistent enough to be separately detectable by two different regulatory methodologies, using two different investigative approaches, more than a year apart.
Where the two actions diverge is in mechanism and trigger. FDA’s Warning Letter is fundamentally a records-access enforcement action under Section 704(a)(4); it does not, on its face, allege a specific manufacturing or product-quality defect, because Zenzi’s non-response prevented FDA from evaluating one directly. Malta’s non-compliance statement, by contrast, followed a completed on-site GMP inspection, and EudraGMDP’s own classification framework generally requires a finding of critical or major deficiencies — critical meaning a finding likely to produce a product harmful to users, major meaning a significant departure from GMP that may not be immediately harmful but indicates a serious quality system malfunction — before a non-compliance statement is issued at all. Put simply: FDA’s exposure traces to a company that would not open its records for review, while the EU exposure traces to an inspection that evidently found something once inspectors examined operations directly. That is a meaningful difference in regulatory posture and evidentiary basis, even where both point toward the same underlying site-level risk.
For US companies, the consequence is immediate and mechanical. Import Alert 66-79 authorizes detention without physical examination of drug products manufactured at this site attempting entry into the United States, and that status does not lift until FDA can independently confirm CGMP compliance, typically requiring a new inspection and a documented response to the outstanding records request. Any company with a contract manufacturing relationship touching this facility, directly or through an intermediary, should confirm whether its own supply chain is exposed — the Warning Letter itself was triggered because a customer’s own documentation named this site as a manufacturer the firm had denied supplying. For EU marketing authorization holders, the practical question is whether any product currently on the EU market lists this site as a manufacturer, and whether the relevant national competent authority is expected to act on the associated marketing authorization following the non-compliance statement, and on what timeline re-inspection might restore compliant status.
This is exactly the kind of cross-jurisdictional exposure that a single-country compliance review will not surface. XGene Consulting helps regulatory affairs, quality, and supply chain teams run cross-jurisdictional CGMP gap assessments that check a supplier’s status against FDA, EMA, and MHRA records concurrently, rather than sequentially and only after a customer’s product surfaces in someone else’s enforcement letter. If your supply chain includes contract manufacturing sites with active multi-authority attention, a supplier verification now costs considerably less than discovering a dual-enforcement gap later, after a regulatory filing or a customer contract already depends on that site. Contact XGene Consulting to scope a cross-jurisdictional supplier risk review before your next inspection or filing cycle.