Los Angeles
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
453- Orthopaedic Surgery
- 453
Shipping cold-chain biologics to the West Coast
Dry-ice shipments to Los Angeles travel the same validated overnight process Precision Biologics uses nationwide: cryopreserved Wharton's jelly products leave on dry ice in a validated shipping container, using slow-rate freezing before transit, and arrive ready for -80 degree Celsius storage.
Orthopedic surgery centers that run a tight receiving schedule sometimes prefer lyophilized formats, which ship shelf-stable and skip the ultra-low freezer step entirely. Either way, Precision Biologics expects the receiving lot number to be logged against the order before product is used.
Documentation an orthopedic group should request first
Before a Los Angeles orthopedic practice adds a new tissue allograft or exosome line, it's reasonable to ask for the certificate of analysis and lot release record tied to the specific lot, along with the donor eligibility summary documenting donor medical and social history review.
Precision Biologics provides this documentation to verified accounts rather than publishing it generally, since release criteria and test results are specific to each lot rather than to the product line as a whole.
NPI verification before the first order
Orders are restricted to licensed professionals, and every Precision Biologics account is matched against the ordering physician's NPI number before activation.
A Los Angeles surgery center with several affiliated surgeons can register each one individually; group purchasing arrangements are still tied to a verified NPI per ordering physician rather than a single blanket account.
Confirming your regulatory position
Whether a given orthopedic application of a Wharton's jelly or exosome product meets the criteria for minimal manipulation and homologous use under 21 CFR 1271.10 is a determination the practice and its counsel need to make on a case-by-case basis; Precision Biologics does not make that determination for buyers.
California practices should confirm licensing and scope questions directly with the Medical Board of California and their own legal counsel before relying on any supplier's framing of a product's regulatory status.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
How are cryopreserved Wharton's jelly products shipped to Los Angeles?+
They ship overnight on dry ice in a validated container and should go directly into -80 degree Celsius storage on arrival.
Does Precision Biologics work with ambulatory surgery centers as well as practices?+
Yes, accounts are opened for any licensed practice or surgery center that completes NPI verification.
Who decides whether a product's intended use qualifies under 21 CFR 1271.10 for a California practice?+
That determination belongs to the practice and its own counsel; Precision Biologics supplies documentation but does not provide a regulatory opinion on intended use.