cGMP supplement manufacturer
21 CFR Part 111 compliance, 8 certifications, 3 in-house facilities in Tampa Bay, FL.
HBM is a cGMP supplement manufacturer operating 3 facilities in Tampa Bay, FL under 21 CFR Part 111. The quality system carries 8 certifications: FDA Registration, NSF, Non-GMO Project Verified, USDA Organic, Ecocert, Health Canada Site License, Florida DBPR, and Made in USA. Batch records, equipment calibration against ASTM E617-23 traceable weight sets, and recall-readiness drills are run in-house. Most contract manufacturers route gummy production to a partner and inherit that partner's quality posture. HBM does not. One quality system covers gummies, liquids, and R&D under one batch record chain.
HBM runs one quality system across gummies, liquids, and R&D. Eight certifications, annual third-party cGMP audits, and equipment calibrated against ASTM E617-23 traceable weight sets.
HBM quality system specs
| Regulatory framework | 21 CFR Part 111 (cGMP for dietary supplements) |
|---|---|
| Certifications | FDA Registration, NSF, Non-GMO Project Verified, USDA Organic, Ecocert, Health Canada, Florida DBPR, Made in USA |
| Cert count | 8 |
| Facility count | 3 facilities in Tampa Bay, FL |
| Calibration standard | ASTM E617-23 traceable weight sets |
| Audit cadence | Annual third-party cGMP audit |
| Batch records | Retained per cGMP, available under NDA |
| Recall posture | Lot-coded traceability + mock recall drills |
cGMP
21 CFR Part 111 compliance audited annually by a third party. Batch records cover identity testing, weights, deviations, and personnel.
cGMP
Health Canada
Site License for Natural Health Products. Supports NPN-licensed SKUs and bilingual labeling into Canada.
Health CanadaAudit and batch records
Per-batch documentation of weights, times, temperatures, equipment, and deviations. Retained per cGMP.
Audit and batch recordsEquipment calibration
Calibrated against ASTM E617-23 traceable weight sets. Equipment register tracks install date, maintenance, and removals from service.
Equipment calibrationRecall readiness
Lot-coded traceability through distribution. Mock recall drills run as part of cGMP audit posture.
Recall readinessHBM quality system vs most contract manufacturers
| HBM | Most contract manufacturers |
|---|---|
| 8 certifications held at the facility level. | Often 2 to 4 certifications, sometimes partner-held. |
| Gummies and liquids share one quality system in-house. | Gummies routed to a partner with separate batch records. |
| Equipment calibrated against ASTM E617-23 traceable weight sets. | Calibration cadence and standard often unspecified. |
| Mock recall drills run as part of annual audit posture. | Recall posture confirmed only when a recall happens. |
| Batch records available under NDA on request. | Batch record access varies by contract. |
How a batch moves through the HBM quality system
- Raw material intake
Each lot enters with a supplier COA. HBM verifies identity before release to production. - Batch record open
Weights, equipment IDs, personnel, and times are logged from the first action onward. - In-process checks
Brix, fill weight, and visual checks run at defined intervals. Deviations trigger documented investigation. - Finished product testing
Identity, potency, and contaminant testing run per the SKU spec. Results sit on the COA. - Release and retention
QA reviews the full batch record before release. Retention samples and records are held per cGMP.
Three equipment removals in five months is the system working. Discovery and removal is the pattern we want.
HBM operations
Frequently asked questions
Is HBM a cGMP supplement manufacturer?
Yes. HBM operates under 21 CFR Part 111, the cGMP framework for dietary supplements. The HBM quality system is audited annually by a third party. Batch records, identity testing, and equipment calibration run under one system across gummies and liquids. HBM retains batch records per cGMP requirements. They are available under NDA on request.
Is HBM FDA registered?
Yes. HBM holds facility-level FDA Registration under the Bioterrorism Act and FSMA for its Tampa Bay sites. Registration is renewed biennially in even-numbered years. FDA does not approve dietary supplements. Registration covers the facility, not specific products. HBM is one of the FDA registered supplement manufacturers operating from Florida.
Does HBM hold NSF certification?
Yes. HBM holds NSF facility registration under NSF/ANSI 173. NSF audits cover cGMP compliance, label accuracy, and contaminant testing. This includes heavy metals, microbial, and pesticide screening. NSF Certified for Sport is a separate program. HBM does not hold that one. Clients can request it for finished SKUs and HBM will route the conversation.
What certifications does HBM hold?
HBM holds 8 certifications at the facility level. The list: FDA Registration, NSF, Non-GMO Project Verified, USDA Organic, Ecocert, Health Canada Site License, Florida DBPR, and Made in USA. Each cert carries its own audit cadence. Most run annually. HBM is one of a small set of NSF supplement manufacturers that also hold Health Canada and Ecocert.
How does HBM handle a recall?
HBM uses lot-coded traceability on every batch. Lot codes tie back to the full batch record. The record covers raw materials, weights, equipment, personnel, and times. Mock recall drills run as part of the annual cGMP audit posture. Batch records are retained per cGMP, typically for shelf life plus one year.
Request a quote.
Formal preliminary estimate in 24 hours. Quality docs available under NDA.
Send to R&D