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# Multiple Incell Violations Cited
- URL: https://www.fdaweb.com/multiple-incell-violations-cited/
- Published: 2025-01-21T12:00:00.000Z
- Updated: 2026-09-14T14:51:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158513

A 9/26-9/29/2023 FDA inspection at Incell Corp. in San Antonio, TX, documented that the company is a contract manufacturer of a product derived from amniotic fluid. A just-released 12/12/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/incell-corporation-llc-679023-12122024?ref=fdaweb.com) says the firm’s product is legally considered to be an unapproved new drug that is manufactured with significant violations of current good manufacturing practice (CGMP) requirements.

The letter says the firm’s product is a drug and biological product that must have a valid BLA in effect, which the company does not have.

The letter also lists these CGMP violations:

- failure to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity; and
- failure to establish a written testing program 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.

FDA says the product is misbranded because its labeling is false and misleading. It also says that documents provided during the inspection lack evidence that adequate environmental monitoring takes place in the redacted ISO manufacturing environment where a redacted item is exposed to the environment during processing.

Incell was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.