Sciarra Aeromed, Inc. MARCS-CMS 728248 — September 23, 2026

WARNING LETTER

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• Delivery Method: Via Email
• Product: Animal & Veterinary; Drugs

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• Recipient: Christopher J. Sciarra; President; Sciarra Aeromed, Inc.; 1791 Route 6; Carmel, NY 10512-2121; United States; c.sciarra@sciarralabs.com

• Issuing Office: Center for Veterinary Medicine; United States

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September 23, 2026

WARNING LETTER
CMS# 728248

Re: 728248
Dear Mr. Sciarra:

This Warning Letter summarizes significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) pertaining to (b)(4).

In response to a series of serious adverse events (b)(4) associated with (b)(4), the United States Food and Drug Administration (FDA) conducted a multistate investigation. As described in more detail below, we collected numerous samples of the product, inspected your manufacturing facility, and reviewed the epidemiological and clinical evidence associated with over (b)(4) individual cases.

Our investigation has linked significant contamination of your purportedly sterile product, (b)(4) to this incident, which involved the largest number of deaths in (b)(4) to be associated with a product quality defect in any FDA-regulated medical product for veterinary use. This incident also resulted in the most fatalities in any species to be associated with microbiological contamination of a purportedly sterile FDA-regulated medical product for veterinary use.

(b)(4)

From February 9, 2026, to February 25, 2026, we inspected your manufacturing facility at 1791 Route 6, Carmel, NY 10512-2121, and issued a Form FDA 483 with our inspectional observations. Our review of the inspectional and related evidence indicates (b)(4) was manufactured under insanitary conditions, rendering it adulterated under the FD&C Act section 501 (a)(2)(A).

During our investigation, we collected and analyzed samples and confirmed that (b)(4) (which purports to be sterile) was, in fact, not sterile, and is therefore adulterated under sections 501 (a)(1) and 501 (c) of the FD&C Act and misbranded under section 502(a). We subsequently reviewed (b)(4) labeling and determined that the product is also misbranded under section 502(f)(1) of the FD&C Act because its labeling fails to bear adequate directions for use.

For the above reasons, the introduction of adulterated and misbranded (b)(4) into interstate commerce is a violation of section 301 (a) of the FD&C Act, 21 U.S.C. 331 (a).

We acknowledged receipt and reviewed below your post-inspection correspondence received on March 18, 2026, in response to Form FDA 483.

You can find the FD&C Act and FDA regulations through links on FDA's homepage at www.fda.gov.

Microbiological Contamination in a Purportedly Sterile Product
Under section 501 of the FD&C Act, "A drug or device shall be deemed to be adulterated ... if ... its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess." FD&C Act section 501 (c), 21 U.S.C. 351 (c). In addition, a drug or device shall be deemed to be adulterated "if it consists in whole or in part of any filthy, putrid, or decomposed substance." FD&C Act section 501 (a)(1), 21 U.S.C. 351 (a).

(b)(4) is adulterated under sections 501 (c) and 501 (a)(1) because it is labeled as "sterile solution" but FDA's laboratory testing of (b)(4) revealed significant microbiological contamination.

FDA's laboratory testing of (b)(4) identified the presence of viable microbiological contaminants, including the following fungal species:

- Purpureocillium lilacinum
- Paraisaria heteropoda
- Gongronella lacrispora
- Purpureocillium sodanum
- lsaria takamizusanensis

The presence of microorganisms in conjunction with the product's labeled indications poses a high risk to patients. When used for its labeled indications (such as (b)(4)), the product has the potential to directly contact the internal bodily tissues and/or enter the systemic circulation. Microbial contamination can cause wound infection, surgical wound dehiscence, cellulitis, tissue necrosis and, in severe cases, sepsis, which may result in death.

(b)(4) is also commonly used off-label as a (b)(4) injection. It is our understanding that this off-label use represents a common manner in which veterinarians use the product in real-world medical practice, and (b)(4) labeling does not contain any limitations, warnings, or contraindications pertaining to this use. Injection of microbiologically contaminated (b)(4) into the (b)(4).

Manufacturing Under Insanitary Conditions

Under section 501 of the FD&C Act, "A drug or device shall be deemed to be adulterated ... if ... it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health." FD&C Act section 501 (a)(2)(A), 21 U.S.C. 351 (a)(2)(A).

Our inspection of your facility found (b)(4) was produced under such insanitary conditions, including the following:

1. Inadequate Cleaning (No Use of Sporicidal Agent)

You did not use a sporicidal agent for cleaning the ISO 7 and ISO 5 areas where (b)(4) is manufactured. We also note that you do not have a cleaning validation to demonstrate the effectiveness of your cleaning or a written cleaning procedure.

Sporicidal agents are cleaning agents capable of killing spores, which can be highly resistant to other disinfection methods. The lack of sporicidal agent use as part of a disinfection rotation program demonstrates an inadequate contamination control strategy. Of note, our laboratory tests identified the presence of multiple fungal microorganisms in (b)(4), including Purpureocillium lilacinum in your product, which is a spore forming fungi.

2. Inadequate Environmental Monitoring During Production

You failed to establish adequate environmental monitoring during production.

You did not perform any viable particulate sampling in the ISO 5 area during the manufacturing of (b)(4). We also note that you do not have any procedure for environmental monitoring.

Viable airborne particulate sampling is used to detect the presence of viable microorganisms in the air that could compromise product sterility. Your failure to conduct viable airborne particulate sampling during production means that you had no real-time assessment of microbial contamination risk during the critical (b)(4) processing operations.

3. Failure to Conduct Personnel Sampling 

You failed to perform adequate personnel sampling during the production of products which purport to be sterile. Specifically, you did not sample operators' gloves or sterile garb for viable microorganisms during production of (b)(4). Additionally, we note that you have no written procedures for performing personnel sampling during manufacturing.

Personnel can be a primary source of microbial contamination in aseptic operations. Your failure to conduct personnel sampling means you had no means of verifying that operators were not contaminating the sterile environment or products during manufacturing.

4. Lack of Smoke Studies

You failed to adequately evaluate the efficacy of the ISO 5 production area.

Specifically, you failed to conduct smoke studies under static and dynamic conditions.

Static smoke studies are necessary to establish that the airflow in the ISO 5 area is laminar (i.e., static smoke studies demonstrating clean air flows directly from the HEPA filters to the product without touching other surfaces, and in a manner that protects the product from exposure to less-clean air), and dynamic smoke studies are necessary to show that (b)(4) manipulations do not interfere with laminar airflow within the ISO 5 environment. Without smoke studies, you had no assurance that the (b)(4) production process maintains unidirectional undisrupted airflow to protect the product from contamination.

5. Facility in Poor State of Repair

You produced (b)(4) in a (b)(4) cleanroom, located in unclassified warehouse space. We observed multiple examples of insanitary conditions and disrepair in the facility. We acknowledge your facility was not in production at the time these conditions were observed; however, the following demonstrate the overall uncleanliness and insanitary nature of the area where the cleanroom is located:

Description: (b)(4) cleanroom, located in unclassified warehouse (b)(4).

 Description: Exit door from the warehouse where the cleanroom is located with large gaps where pest ingress can occur. The area contains numerous black and brown residues of unknown identity.

Description: Ceiling leaks and brown staining appear to be water damage next to unclassified weigh booth of cleanroom suite.

Description: Closeup of ceiling near cleanroom

6. Inadequate Gowning

Operators do not wear appropriate garb to protect the cleanroom from contamination.

Gowning worn in the ISO7 cleanroom during sterile production exposes skin on the face and ankles. The hairnets, glasses, masks, and shoe covers used by your firm are not sterile.

7. Inadequate Manufacturing Process

You failed to demonstrate your manufacturing processes can consistently produce sterile products.

You did not conduct a media fill that simulates (b)(4) production for (b)(4) vial). Although you conducted media fills for (b)(4) vials, the (b)(4) size represents the worst-case scenario because this size is the most difficult to fill (b)(4) while maintaining (b)(4) conditions.

Your media fills are inadequate and do not demonstrate that your (b)(4) production process (e.g., your equipment, personnel, components, and procedures) can consistently produce sterile products.

Misbranding Violations

As the manufacturer of (b)(4), you package and label the finished product.

Under section 502 of the FD&C Act, "A drug or device shall be deemed to be misbranded ... unless its labeling bears (1) adequate directions for use." FD&C Act section 502(f)(1), 21 U.S.C. 352(f).

(b)(4) labeling lists numerous indications for which minimal to no instructions for use are given. Furthermore, these indications are generally not appropriate for diagnosis and treatment by a layperson, and it is therefore not possible to write adequate directions for use by laypersons. These indications include:

(b)(4)

Neither (b)(4) label, nor its product packaging, indicates it is for use only by, or under the supervision of, a licensed veterinarian. (b)(4) labeling fails to bear adequate directions for use by laypersons, and it is therefore misbranded under section 502(f)(1) of the FD&C Act.

In addition, a drug or device shall be deemed to be misbranded "if its labeling is false or misleading in any particular." FD&C Act section 502(a), 21 U.S.C. 352(a). (b)(4) is misbranded under section 502(a) of the FD&C Act because it is labeled as "sterile solution" but FDA's laboratory testing of (b)(4) revealed significant microbiological contamination.

Corrective Actions

We have reviewed your firm's responses to Form FDA 483. We acknowledge you are not currently in production and your statement that you intend to make corrections before resuming production. Regarding your response related to the insanitary conditions, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:

1. Your response does not include data for media fills to simulate (b)(4) production of (b)(4).

2. Your response did not provide evidence you will be conducting adequate personnel monitoring during production in the ISO 7 suite and ISO 5 area.

3. Your response failed to provide adequate evidence that you will be using a sporicidal agent during cleaning operation in the ISO 7 suite and ISO 5 area, or evidence to demonstrate adequate overall disinfection of the (b)(4) processing environment.

4. Your response failed to provide data and evidence of differential pressure gauge and temperature monitoring for the sterile cleanroom, including between the ISO 7 cleanroom and the unclassified weigh booth.

5. Your response failed to provide data and evidence for the use of settling plates or other viable particulate sampling in the ISO 5 area environment during production.

6. Your firm failed to provide data and evidence of smoke studies performed under dynamic conditions for the ISO 5 laminar flow hood.

Consultant Recommended

You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing (b)(4) manufactured sterile veterinary medical products. Based upon the nature of the violations we identified at your firm, you should engage a qualified consultant to assist your firm in avoiding insanitary manufacturing conditions using current industry standards for (b)(4) manufacturing requirements before continuing manufacturing of products that are intended to be sterile.

Your use of a consultant does not relieve your firm's obligation to comply with the FD&C Act and FDA's regulations. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing compliance with applicable sections of the FD&C Act [21 U.S.C. §§ 301 et seq.]

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you with an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address any violation may lead to regulatory, or where appropriate, legal action.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The FDA CVM, Office of Surveillance and Compliance, is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility's name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.

Send your electronic reply to CVM-483-Responses@fda.hhs.gov. On your communications, refer to the Warning Letter CMS# 728248 and ATTN: Juan Jimenez, Regulatory Scientific Reviewer, juan.jimenez@fda.hhs.gov.

Sincerely,
/S/

Brett Havranek, J.D.
Acting Director
Division of Drug Compliance
Office Surveillance and Compliance
Center for Veterinary Medicine