BatchBuddy gives dietary supplement brands the compliance infrastructure to own their quality story, COA management, lot traceability, CAPA documentation, and recall readiness, whether you manufacture in-house or through a contract manufacturer.
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from 2023 to 2024. The #1 cited issue: missing finished product specifications. The #2: incomplete batch records. Both are brand-owner responsibilities.
"Product specifications for identity, purity, strength, and composition were not established." If your name is on the label, this is your gap to close, not your CM's.
The FDA is explicit: "A firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement cGMP requirements, regardless of who actually performs the operations."
In plain language: your contract manufacturer's 483 observation becomes your problem. Their batch record gap becomes your recall risk. Their missing COA becomes your FDA warning letter.
Most supplement brands have no visibility into their CM's documentation until something goes wrong. By then it's public, on FDA's website, in your retailer's supplier qualification system, and in your customers' social feeds.
A recall doesn't distinguish between the brand and the manufacturer. Your customers just see your name.
Whether you manufacture in-house, through a CM, or both, every specification, every COA, every lot trace, and every corrective action lives in one signed, searchable, tamper-evident system.
The FDA's top 21 CFR Part 111 citation for two consecutive years: missing or inadequate finished product specifications. BatchBuddy's formula and specification management links every product to its identity, purity, strength, and composition requirements, and verifies every batch against them. When an inspector asks for your finished product spec, the answer is immediate and documented.
Relying solely on a supplier's COA without independent verification is insufficient under 21 CFR Part 111. BatchBuddy imports COAs via OCR, HMAC v2 signs every certificate, and links each COA to the lot it covers. Out-of-spec COAs automatically trigger your OOS workflow. You have documented evidence of every supplier decision.
If a lot is compromised, you need to know every customer who received product from it, and every supplier lot that went into it, within hours. BatchBuddy traces every ingredient lot through production to finished goods and customer shipments, forward and backward, in one search. FSMA 204 compliant. Retailer audit ready. Recall response ready.
When something goes wrong, an OOS result, a label error, a supplier deviation, the FDA expects a structured investigation with root cause, corrective action, and effectiveness verification. BatchBuddy's CAPA module captures that chain automatically at the moment of the event. When an auditor asks about your last nonconformance, you open BatchBuddy.
BatchBuddy's bidirectional recall simulation runs on your live production data, forward to every customer shipment, backward to every supplier lot. The signed, locked report is ready for the FDA, your retailer, or your legal team on demand. Most supplement brands find out they weren't recall-ready during an actual recall. Now you can find out during a drill.
Every record in BatchBuddy is SHA-256 hash-chained and append-only. Nothing can be altered, backdated, or deleted after it's committed. When a retailer's supplier qualification team asks for your audit trail, or when the FDA asks who reviewed a batch record and when, the answer is immediate and tamper-evident. That's the quality story your brand deserves.
Major supplement retailers, Whole Foods, Target, iHerb, Amazon, conduct supplier qualification reviews before placing an order. They ask for your GMP certification status, your most recent third-party audit, your finished product specifications, your COA review process, and your recall procedure.
Brands who can produce a complete, signed documentation package in a day win the contract. Brands who say "we'll have to check with our CM" lose it.
BatchBuddy gives your sales and business development team a quality infrastructure they can walk a retail buyer through on a live call, specifications, COA history, lot traceability, CAPA log, all signed and searchable. That documentation becomes your competitive advantage.
"We're a brand, not a lab. Before BatchBuddy, staying on top of COAs, lot traceability, and documentation requirements meant either hiring someone full-time to manage it or hoping our CM had everything in order. Now we have visibility into every lot, every COA, every batch, signed and searchable. When a retailer asks for documentation, we pull it up in the call. That's changed how buyers see us."
A brand-owner's guide to 21 CFR Part 111 compliance, covering finished product specifications, COA oversight, lot traceability, CAPA documentation, and recall readiness. Know exactly what the FDA expects of your brand, whether you manufacture yourself or through a CM.
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For Brand Owners & Dietary Supplement Companies
BatchBuddy gives supplement brands the compliance infrastructure to own their quality story, satisfy retailer qualification requirements, and know their recall exposure, before anything goes wrong.
No credit card required • View Pricing • Also work with a contract manufacturer?