cGMP supplement manufacturer
21 CFR Part 111 compliance across gummies and liquids. One quality system, one batch record chain.
HBM is a cGMP supplement manufacturer operating under 21 CFR Part 111 across three Tampa Bay, FL facilities. The gummy plant in St. Petersburg runs two 30,000 sq ft buildings plus a 3,000 sq ft R&D lab, all temperature controlled. HBM holds 8 certifications. These include FDA Registration, NSF, USDA Organic, Non-GMO Project Verified, Ecocert, Health Canada Site License, Florida DBPR, and Made in USA. Third-party cGMP audits run annually. Every batch ties to an equipment register, an identity-tested raw material lot, and a signed batch record. Most contract manufacturers route production to a partner. HBM does not.
Buyers ask the cGMP question because the answer separates a manufacturer from a broker. cGMP is not a logo. It is a daily operating system covering identity testing, batch records, equipment calibration, deviations, and recall readiness. This page covers how HBM runs cGMP across the gummy and liquid lines, what auditors look at, and what a buyer can request under NDA.
What cGMP means for a supplement manufacturer
cGMP for dietary supplements lives in 21 CFR Part 111. The rule defines identity testing on incoming raw materials, written master manufacturing records, per-batch production records, equipment calibration, complaint handling, and recall readiness. FDA inspects on-site. Third-party auditors run their own cGMP audits on top. HBM holds FDA facility registration and is audited annually by third parties under NSF and equivalent programs. The rule is granular. Every raw material lot needs identity verification before it enters production. Every finished batch needs a record showing weights, times, temperatures, equipment, personnel, and any deviations. Records are retained for the product shelf life plus one year.
How HBM runs cGMP across the gummy line
Every raw material lot is identity-tested on arrival. Pectin, tapioca syrup, cane sugar, allulose, FOS, actives, flavors, and colors all go through verification. Lots that fail identity are quarantined and returned. The equipment register is the spine of HBM’s cGMP system. Every piece of production equipment has a record. It covers install date, calibration history, preventive maintenance, deviations, and root-cause analysis when something fails. Three equipment removals in five months means the system is working. Discovery and removal is the desired pattern. Each gummy batch generates a signed batch record. Depositor speeds, slab temperatures, cooling tunnel residence times, coating weights, and packaging line counts all log to the record. The four continuous depositing stations run at 300KG/hour each (two run at a time). Each station logs independently.
GMP compliance for nutraceuticals: the liquid side
GMP compliance for nutraceuticals follows the same 21 CFR Part 111 framework on the liquid line. HBM’s liquid facility carries 2,500L of mixing capacity across four jacketed vessels. Each vessel logs temperature, mix time, RPM, and operator sign-off per batch. Fill lines log fill weights at start, mid-batch, and end. Out-of-spec fills trigger an immediate hold and a deviation report. The same identity testing, batch record, and equipment register rules apply across syrups, shots, tinctures, emulsions, and liposomal SKUs.
Calibration and traceability
Scales, fill heads, and thermocouples are calibrated against ASTM E617-23 traceable weight sets and NIST-traceable temperature standards. Calibration cadence follows the equipment register schedule. Out-of-tolerance findings open a deviation and quarantine any batch produced since the last passing calibration. Lot codes on finished packaging tie back to the batch record. A buyer or auditor can trace any unit in the field to the raw material lots, the equipment used, and the operators who ran the batch.
Audits and batch records
HBM’s annual third-party cGMP audit covers identity testing, batch records, equipment calibration, personnel training, complaint handling, and recall readiness. FDA inspections are facility-level and may occur on a separate schedule. Under NDA, HBM provides batch records, COAs, identity testing results, and the cGMP audit summary to brand owners. See audit and batch record access for the request process.
Frequently asked questions
Is HBM a cGMP supplement manufacturer?
Yes. HBM operates under 21 CFR Part 111 across three Tampa Bay, FL facilities. Third-party cGMP audits run annually. The audit covers identity testing, batch records, equipment calibration, deviations, and recall readiness. HBM also holds FDA facility registration, NSF, USDA Organic, Non-GMO Project Verified, Ecocert, Health Canada Site License, Florida DBPR, and Made in USA. That is 8 certifications in total.
Can I see batch records for my SKU?
Yes. Under NDA, HBM provides batch records, COAs, and identity testing results. The request goes through R&D and is fulfilled per batch. Each record shows weights, times, temperatures, equipment used, personnel sign-offs, and any deviations. Records are retained for the product shelf life plus one year per 21 CFR Part 111.
How does HBM handle a recall?
HBM uses lot-coded traceability on every finished unit. The lot code ties back to the full batch record, the raw material lots, and the equipment register entries. Mock recall drills are part of the annual cGMP audit posture. If a recall is triggered, HBM can identify every unit produced from the affected batch within the cGMP-required timeframe.
Does FDA approve HBM's products?
No. FDA does not approve dietary supplements. HBM holds facility-level FDA Registration under the Bioterrorism Act and FSMA. The registration is renewed biennially. FDA may inspect the facility on-site, announced or unannounced. Product safety and label accuracy are the manufacturer's responsibility under cGMP. HBM's quality system is built to that standard.
What is the difference between cGMP and GMP compliance for nutraceuticals?
The 'c' stands for 'current.' cGMP means the manufacturer follows the current version of 21 CFR Part 111, not an older interpretation. For nutraceuticals, GMP compliance is the same framework. HBM's quality system tracks rule updates and third-party audit findings. The system is updated when the standard moves. Practically, the two terms are used interchangeably in the industry.
Related pages
Talk to R&D about your cGMP requirements.
Batch records, COAs, and audit summaries available under NDA.
Talk to R&D