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# FDA Warns American CryoStem About Atcell Violations
- URL: https://www.fdaweb.com/fda-warns-american-cryostem-about-atcell-violations/
- Published: 2018-01-04T12:00:00.000Z
- Updated: 2026-09-14T23:11:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140419

A 7/17-7/26/17 FDA inspection at American CryoStem Corp., Monmouth Junction, NJ, documented that the firm receives and processes adipose tissue for autologous use, according to a 1/3 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm?ref=fdaweb.com). The firm reportedly isolates cellular components from the adipose tissue and processes the tissue into stromal vascular fraction, that is expanded through cell culture to produce the firm’s Atcell product. The letter says the autologous product is then shipped back to doctors to treat patients for a variety of diseases or conditions by various routes of administration.

The letter says FDA regulates Atcell as a drug and a biological product and notes that such products must have a valid biologics license in effect. Licenses are issued only after a showing that the product is safe, pure, and potent, the letter adds.

Current good manufacturing practice deviations documented during the inspection and following a review of documents collected during the inspection were: 

- failing 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;
- failing to establish and follow written production and process control procedures designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to assure a system for monitoring environmental conditions is in place to prevent contamination during aseptic processing;
- failing to perform operations in areas with control systems necessary to prevent contamination or mix-ups during aseptic processing;
- failing to maintain laboratory controls that include establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components, and drug product containers and closures;
- failing to ensure that each batch of components, drug product containers, and closures are withheld from use until the lot had been sampled, tested, or examined, as appropriate, are released for use by the quality control unit;
- · failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates;
- failing to use appropriate air filtration systems for production areas; and
- failing to adequately design the facility with adequate separation or defined areas or other such control systems necessary to prevent contamination or mix-ups.

In addition, the letter says, significant deviations in the manufacture of Atcell intermediates were observed during the inspection involving buildings and facilities, equipment, control of components, microbiological control, production and process controls, and laboratory controls.

The firm’s 8/16/17 written response committed to certain corrective actions, FDA says, but many of the proposed corrections are inadequate, incomplete, or lack sufficient detail to be fully evaluated.

Further, the agency says, while the company contends that it manufactures Atcell for research use only, an IND must be in effect to lawfully distribute Atcell for clinical use in humans while it is being developed and studied. The fact that an institutional review board has reviewed and approved a study does not equate to having an IND in effect, FDA says.

American CryoStem was told to take prompt action to correct the deviations and to respond with a list of additional steps it has taken or will take to correct the violations and prevent their recurrence, with a timetable for completion.

Commenting on the Warning Letter, FDA commissioner **Scott Gottlieb** [said](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591371.htm?ref=fdaweb.com) that as “part of our comprehensive policy framework for the efficient development and regulation of cell-based regenerative medicine, we’re going to be stepping up enforcement activities against those who manufacture and market products in ways that put patients at risk. We see great promise from the field of cell based regenerative medicine, but there are also novel risks. Our goal is to implement a new policy framework in a way that helps this promising field advance, while making sure that we address issues that can put patients at risk. It also means taking an efficient, risk-based approach to making sure that products undergoing more than minimal manipulation, which makes them subject to FDA’s review and approval, and particularly products intended to treat serious and/or life-threatening disease or conditions, must prove that they deliver the benefits they’re promising to patients.”