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# Multiple Violations at Re-Gen Active Lab
- URL: https://www.fdaweb.com/multiple-violations-at-re-gen-active-lab/
- Published: 2022-06-28T12:00:00.000Z
- Updated: 2026-09-14T17:50:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152179

A 7/19-7/28/21 FDA inspection at Re-Gen Active Lab, an Irving, TX, manufacturer of cellular products for allogeneic use, found multiple violations, including marketing the products illegally without required agency approvals. A just-released 5/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/re-gen-active-lab-inc-620763-05272022?ref=fdaweb.com) says the inspection also found evidence of significant deviations from current good manufacturing practice (CGMP) regulations. Specific CGMP deviations were:

- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validating the aseptic process;
- failing to routinely calibrate, inspect, or check automatic, electronic, or mechanical equipment or other types of equipment, including computers or related systems that will perform a function satisfactorily, that are used in the manufacture, processing, packing, and holding of a drug product, according to a written program designed to assure proper performance;
- failing to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of a drug product;
- failing to establish written procedures describing in sufficient detail the cleaning methods, equipment, and materials to be used in cleaning the buildings and facilities;
- failing to satisfy general biological products standards for sterility testing;
- failing to establish and follow written procedures describing in sufficient detail the receipt, identification, shortage, handling, sampling, testing, approval, or rejection of components and drug product containers and closures;
- failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates; and
- failing to prepare batch production and control records for each batch of drug product produced that include complete information relating to the production and control of each batch, including documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished.

The letter says the firm’s response to the inspection observations was inadequate and did not include sufficient details for FDA to fully assess the adequacy of the proposed corrective actions.

Re-Gen was told to respond with a list of specific steps it has taken or plans to take to correct the violations and prevent their recurrence, with documentation to show that the correction has been achieved and a timetable for completing the corrections.