WARNING LETTER
Ningbo Riway Industrial Co., Ltd.
MARCS-CMS 692870 —
April 30, 2025
Delivery Method:
VIA UPS
Reference #:
320-25-69
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. David Duan
Recipient Title
General Manager
Ningbo Riway Industrial Co., Ltd.
No. 555 Binhai Avenue Building E1, Binhai Wanyang Creative City
Binhai New Area, Economic Development Zone
Fenghua Shi
Ningbo Shi
Zhejiang Sheng
,
315524
China
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-25-69
April 30, 2025
Dear Mr. Duan:
Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act for your facility, Ningo Riway Industrial Co., Ltd., FEI 3016905536, at No. 555 Binhai Avenue, Building E1, Binhai Wanyang Creative City, Binhai New Area, Economic Development Zone, Fenghua District, Ningbo, Zhejiang.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).
Unapproved New Drug and Misbranded Drug Violations
In addition, KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
704(a)(4) Request for Records and Related CGMP Violations
Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:
1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Your firm manufactures OTC drug products, including antimicrobial hand wipes. Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of incoming components (e.g.,
(b)(4)
and isopropyl alcohol) used in the manufacture of your drug products. You also accept your suppliers’ certificates of analyses (COAs) without verifying the test results at appropriate intervals. In your response, while you state that you review the COA of your components, you did not state that you test your incoming components, including to perform
(b)(4)
limit testing for your
(b)(4)
or methanol for isopropyl alcohol (IPA) components.
(b)(4)
Identity testing for
(b)(4)
and certain other high-risk drug components include a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of
(b)(4)
. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.
The use of ingredients contaminated with
(b)(4)
has resulted in various lethal poisoning
(b)(4)
to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for
(b)(4)
contamination at
(b)(4)
.
Isopropyl Alcohol
You failed to adequately test your incoming IPA, which is used as an active ingredient, for methanol. The use of IPA contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
to help you meet the CGMP requirements when manufacturing drugs containing IPA at https://www.fda.gov/media/173005/download.
Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.
2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Based on the records and information you provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution. For example, the test reports that you provided in your response, did not include an appropriate assay test for active ingredient content or impurities. Additionally, the records you provided did not contain adequate microbiological tests as some of the products you manufacture are labeled as sterile. Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.
3. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU failed to ensure that your water system used in the manufacture of your OTC sterile IPA prep pads, is appropriately designed and monitored, and to adequately exercise its authority in the approval or rejection of components in your Materials System.
Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations.
See FDA’s guidance document
Quality Systems Approach to Pharmaceutical CGMP Regulations
for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
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 if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
Unapproved New Drug and Misbranded Drug Violations
Your KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES products are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.
Examples of claims observed on the KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES product labels provide evidence of the intended use (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following:
KLEAN FREAK BODY WIPE
“DRUG FACTS” ; “Purpose Antibacterial” ; “Use: To decrease bacteria on the skin.” [from product label]
JJ CARE ADHESIVE REMOVER WIPES
“DRUG FACTS” ; “Purpose Antiseptic” [from product label]
Unapproved New Drug Violations
Based on the above labeling evidence, KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES are intended for use as topical antiseptic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 USC 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your KLEAN FREAK BODY WIPE or JJ CARE ADHESIVE REMOVER WIPES drug products are GRASE for use under the conditions suggested, recommended, or prescribed in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order under section 505G(b). Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
KLEAN FREAK BODY WIPE
Over-the-counter (OTC) topical antiseptic products had been the subject of rulemakings under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016) (Consumer Antiseptic Rubs Proposed Rule).
Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub. Additionally, health care topical antiseptics were addressed in the 1994 TFM, as further amended by “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015) (Health Care Antiseptics Proposed Rule), and “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Final Rule, 82 FR 60474 (December 20, 2017) (Health Care Antiseptics Final Rule). Over the course of these rulemakings, six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine) were classified as Category III for use in health care antiseptic products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a health care antiseptic, including for use as a patient antiseptic skin preparation.
Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements.
Under section 505G(a)(3), drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for a drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they meet the relevant conditions outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.
Your KLEAN FREAK BODY WIPE product does not conform to the 1994 TFM, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
As labeled, your product KLEAN FREAK BODY WIPE includes an intended use beyond what is permitted in the applicable rulemaking for consumer antiseptic rub products. Specifically, the label includes the description “Body Wipe,” and the “Directions” section of the product label includes the statement, “…wipe down that dirty body…yep…even all those nooks and crannies.” The monograph conditions of use for consumer antiseptic rubs set forth in the rulemakings described above limit the use of the product to the hands and do not include application to the whole body. Therefore, your product does not conform to the TFM or the applicable requirements and goes beyond describing the intended use of consumer antiseptic rub products as set forth in the 1994 TFM and amended by the 2016 Consumer Antiseptic Rubs Proposed Rule.
1
The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
JJ CARE ADHESIVE REMOVER WIPES
As labeled, JJ CARE ADHESIVE REMOVER WIPES is intended for use as a topical antiseptic drug product and contains the active ingredient “Isopropyl Alcohol 1%.” However, this product does not meet the conditions under section 505G of the FD&C Act for marketing without an approved application under section 505, whether as a consumer or healthcare antiseptic rub or as a first aid antiseptic. JJ CARE ADHESIVE REMOVER WIPES’ labeled concentration of isopropyl alcohol is less than the required concentration of 70 to 91.3 percent for this active ingredient for either a consumer or healthcare antiseptic rub product. Your JJ CARE ADHESIVE REMOVER WIPES product therefore does not conform to the 1994 TFM, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
Likewise, JJ CARE ADHESIVE REMOVER WIPES does not conform to the conditions in Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for Over-the-Counter Human Use (henceforth “M003”). Under section 505G(a)(1), a nonprescription first aid antiseptic drug product, in order to be GRASE and not a new drug must, among other things, conform to the conditions in the applicable OTC monograph, here M003. However, JJ CARE ADHESIVE REMOVER WIPES’ labeled concentration of isopropyl alcohol is less than the required concentration of 50 to 91.3% by volume in an aqueous solution for this active ingredient, as specified in M003. Thus, JJ CARE ADHESIVE REMOVER WIPES do not comply with the applicable conditions specified in M003. Because this product has not otherwise been found GRASE, it is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis for marketing it without an approved application under section 505G of the FD&C Act. Because there is no approved application in effect for this product, it is an unapproved new drug. The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
The products KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
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.
FDA placed your firm on Import Alert 66-40 on November 7, 2024.
Correct any violations promptly. 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 inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Ningo Riway Industrial Co., Ltd., FEI 3016905536, No. 555 Binhai Avenue, Building E1, Binhai Wanyang Creative City, Binhai New Area, Economic Development Zone, Fenghua District, Ningbo, Zhejiang, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission.
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 3016905536 and ATTN: Daniel W. Brisker.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
/S/
Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
CC:
Registered U.S. Agent
Jake Sztejman
President
Pro Medical Supplies Inc.
Jake.sztejman@outlook.com
__________________________
1
The 2015 Health Care Antiseptics Proposed Rule covered health care antiseptic products intended for use without water. Under the 1994 TFM, as amended by the 2015 Health Care Antiseptics Proposed Rule and 2017 Health Care Antiseptics Final Rule, certain health care topical antiseptic products intended for use without water, including patient antiseptic skin preparations, are permitted. Your KLEAN FREAK BODY WIPE product does not meet the monograph conditions of use for OTC patient antiseptic skin preparation products, as set forth in the healthcare topical antiseptic rulemakings described above, including because its labeling does not include directions for use as a patient antiseptic skin preparation.
Content current as of:
05/13/2025
Regulated Product(s)
Drugs
Over-the-Counter Drugs