WARNING LETTER
Horizon Tool Inc.
MARCS-CMS 706567 —
June 06, 2025
Delivery Method:
Via Email
Reference #:
320-25-79
Product:
Drugs
Recipient:
Recipient Name
Mr. Sean M. Kenny
Recipient Title
President
Horizon Tool Inc.
7918 Industrial Village Road
Greensboro
,
NC
27409
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-25-79
June 6, 2025
Dear Mr. Kenny:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Horizon Tool Inc., FEI 3016555297, at 7918 Industrial Village Rd, Greensboro, from January 14 to 16, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your February 6, 2025 response to our Form FDA 483 in detail.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).
You manufacture over-the-counter (OTC) drug products, such as antibacterial soaps. You failed to perform microbiological testing for your AllShield E2 Sanitizing Hand Soap. Batch records for lot 25009 indicated you did not take the required sample for microbiological testing, and quality assurance was unable to explain why the sample was not collected or the testing performed. Without testing each batch prior to release, you do not have scientific evidence that all drug product batches conform to the appropriate microbiological standards and are suitable for release to consumers.
In your response, you acknowledge that you lacked established product specifications, including microbiological limits, for your AllShield E2 Sanitizing Hand Soap. You identify the root cause as “lack of product development and not following federal regulations.” You also commit to completing product development activities and approving specifications prior to full-scale manufacturing of your AllShield E2 Sanitizing Hand Soap.
Your response is inadequate. You do not provide sufficient details and supporting documentation describing how you will ensure AllShield E2 Sanitizing Hand Soap meets appropriate microbiological standards prior to release. Additionally, you do not provide a retrospective risk assessment for the distributed batches.
In response to this letter, provide:
A list of chemical and microbial test methods and specifications used to analyze each lot of your drug products before making a lot disposition decision, and the associated written procedures.
A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
2. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
You informed investigators during the inspection, that you lacked a stability testing program for your AllShield E2 Sanitizing Hand Soap. Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes throughout the use period.
Your response acknowledges that you did not perform stability testing for your AllShield E2 Sanitizing Hand Soap and commits to creating a product development plan that includes stability testing.
Your response is inadequate because it lacks sufficient detail and does not provide a retrospective risk assessment for your AllShield E2 Sanitizing Hand Soap released without stability testing.
In response to this letter, provide:
A comprehensive, independent assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
o Stability indicating methods.
o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.
o Detailed definition of the specific attributes to be tested at each station (timepoint).
All procedures that describe these and other elements of your remediated stability program.
3. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).
You failed to perform adequate identity testing on your incoming components, including active ingredients, before using them in manufacturing your AllShield E2 Sanitizing Hand Soap. Additionally, you failed to ensure that microbiological testing was performed on your benzalkonium chloride solution API, which is required by the United States Pharmacopeia (USP) monograph. Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.
In your response, you acknowledge that your raw materials procedure “is not robust enough to support raw material testing for drug products.” You plan to revise your raw materials procedure, create testing methods, and train your employees.
Your response is inadequate. You fail to provide sufficient details regarding how you will ensure that at least one identity test for each lot of incoming raw materials is performed.
In response to this letter, provide:
A comprehensive independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.
A summary of your program for qualifying and overseeing contract facilities that test the components you use to manufacture drug products.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements.
Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3016555297 and ATTN: Renee A. Marcsisin.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
06/17/2025
Regulated Product(s)
Drugs