Vetting standards
Every manufacturer in the network is assembled from public records first and the company's own account of itself second — in that order, and labelled so you can tell which is which. This page is what that means in practice, including the parts we cannot verify.
The identity anchor is an FDA record, not a form
A manufacturer enters the network through registry data, not through a signup. The anchor is the FDA Establishment Identifier — an FEI is assigned by the agency and cannot be self-asserted, which makes it the one field on a profile nobody can invent. 325 profiles currently carry at least one real facility ID.
Around that we assemble the drug establishment registration, cGMP status, MoCRA registration, inspection classifications, warning letters, recalls and import refusals — all of it from public federal records, none of it taken on a manufacturer's word.
Every value carries where it came from
Facts arrive at different levels of confidence and the interface never flattens them. A capability a manufacturer stated and a capability we inferred from the formats they publish are both useful and are not the same claim, so they are rendered differently and scored differently.
| Provenance | What it means |
|---|---|
| Registry-verified | Read from a federal register. The manufacturer cannot change it and neither can we. |
| Manufacturer-reported | They told us. Shown as their statement, not as a checked fact. |
| Directory data | Published by the company on its own site or in a trade listing. |
| Inferred | Derived from something else on the record — a process implied by a format they make. Labelled as inference everywhere it appears, and shown as a range rather than an exact figure where it is a number. |
A shortlist row shows a minimum as a range, not a figure, whenever that minimum was inferred. Roughly a third of shortlisted manufacturers publish no minimum at all — and that is shown as a question to ask, never as a fit.
A missing field is a missing field
This is the rule we break most carefully. A profile that does not state a lead time has not told us it is slow; a profile with no certification listed has not told us it is uncertified. Most fields on most profiles have no public source, so treating silence as a negative would rule out most of the network on the basis of paperwork nobody was asked to file.
So an unanswered question never excludes a manufacturer from a shortlist. It appears as an open question against their row, which is what it is. A manufacturer is only ruled out when a record actively contradicts what you asked for.
Compliance history ranks. It does not disqualify.
An enforcement record moves a manufacturer down a shortlist and is always shown alongside the rank it affected, with how much it cost. It does not silently remove them: a shortlist that quietly omitted a firm would be making a decision on your behalf and not telling you it had.
The reverse matters as much. A warning letter the FDA has formally closed is agency-verified remediation, and it renders as a positive — showing it as a red flag would punish a manufacturer for fixing the problem. A clean inspection result is shown as the clean result it is. And a letter on record with no close-out either way is shown as exactly that, rather than being read as open.
The gates that are absolute
A small number of requirements are legal rather than commercial, and no amount of fit outranks them. A sunscreen, an acne treatment, an antiperspirant or an anti-dandruff product is a regulated OTC drug in the United States, and a manufacturer without drug establishment registration cannot make one. That gate fires from the product itself, before you declare anything — you do not have to know it applies to be protected by it.
What we do not claim
- We do not inspect facilities. Nothing on a profile is a site audit, and none of it substitutes for your own due diligence before you sign.
- We do not verify pricing, lead times or capacity. Those come from the manufacturer and are shown as their statement.
- We do not rank on payment. No manufacturer can buy a position, and the fee is charged only on an introduction that both sides accepted.
- We do not guarantee a manufacturer will take your project. A shortlist is a set of well-matched options, not a set of commitments.
- Public records lag. An inspection or an enforcement action may exist that has not yet reached the registers we read.
Correcting a profile
If you are a manufacturer and something on your profile is wrong, tell us and we will fix it — a mistaken enforcement flag or a stale minimum costs you work, and we would rather hear about it than have it sit there. Profile claiming, which is how you will keep minimums, lead times and capacity current yourself, is being built.