Any of you head of Platinum Biologics? Legal? Is it a regenerative labs made product?

• Failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes.
• Failed to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Failed to perform non-viable particulate monitoring, active or passive viable air sampling, or sampling of critical surfaces in the BSC for microorganisms in association with each production batch.
• During the inspection, FDA investigators observed personnel practices that do not adequately protect against microbiological contamination of products, such as the use of non-sterile protective equipment.

1. books.google.com/books?id=H7mmNS825CgC
2. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/row1-inc-dba-regenative-labs-638823-06212023

anonymous said:

In my opinion, the below is some good information. I do worry because the whole same staff including the doctor moved under the name of another Flordia company and they are still selling these questionable products. They all seem very similar.

Regenerative Labs received a warning letter from the FDA on June 21, 2023, for failing to comply with current good manufacturing practices (cGMPs) for manufacturing sterile drug products. Specifically, the FDA found that Regenative Labs:

• Failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes.
• Failed to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Failed to perform non-viable particulate monitoring, active or passive viable air sampling, or sampling of critical surfaces in the BSC for microorganisms in association with each production batch.
• During the inspection, FDA investigators observed personnel practices that do not adequately protect against microbiological contamination of products, such as the use of non-sterile protective equipment.

The FDA warning letter is a serious matter, but it does not mean that Regenative Labs is an illegal company. It simply means that they are not in compliance with cGMPs, which are the regulations that govern the manufacturing of drug products. The FDA is giving Regenative Labs an opportunity to address the violations and come into compliance. If they do not, the FDA could take further action, such as seizure or injunction.

It is important to note that the FDA has not approved any stem cell products for marketing in the United States. This means that any company that is marketing stem cell products is doing so without FDA approval. The FDA is concerned about the safety of stem cell products, and they are warning consumers to be cautious about using these products.

If you are considering using Regenative Labs or any other company that is marketing stem cell products, you should talk to your doctor first. Your doctor can help you assess the risks and benefits of these products and make an informed decision about whether or not to use them.

Sources

1. books.google.com/books?id=H7mmNS825CgC
2. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/row1-inc-dba-regenative-labs-638823-06212023

The question is after the FDA raided these facilities is this just an alter ego to Regentative Labs?

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