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WARNING LETTER

TCT Nutraceuticals SDN. BHD MARCS-CMS 680743 —


Delivery Method:
VIA EMAIL WITH READ RECEIPT
Product:
Drugs

Recipient:
Recipient Name
Mr. Nurshakinah Mohd
TCT Nutraceuticals SDN. BHD

No. 13 Jalan PP11/3
Taman Putra Perdana
47130 Puchong
Selangor
Malaysia

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


Warning Letter 320-24-39

June 5, 2024

Dear Mr. Mohd:

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 June 16, 2022, and July 8, 2022, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, TCT Nutraceuticals SDN. BHD, FEI 3017270745, at No. 13 Jalan PP11/3 Taman Putra Perdana, Puchong.

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 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).

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 (21 CFR 211.84(d)(1)).

Your firm manufactures Antibacterial Hand Sanitizer Gel. Based on the records and information provided, you did not demonstrate you are adequately testing the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate you are testing your active ingredient isopropyl alcohol for methanol.

Without adequate testing you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality, including testing for the presence of methanol in isopropyl alcohol.

The use of alcohol 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, at https://www.fda.gov/media/173005/download.

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 provided, you did not demonstrate you conducted adequate finished drug product testing on your drug products. For example, the certificate of analysis (COA) reports that you provided does not include an appropriate assay test for active ingredient (isopropyl alcohol) content or impurity testing. Also, you did not provide the test methods used by your firm.

Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure your drug products conform to appropriate specifications before release. Additionally, method validation and verification are necessary to support reliable determination of identity, strength, quality, and purity of drugs. Without evaluating the validity of methods, you lack the basic assurance that your laboratory data accurately reflects drug product quality.

3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Based on the records and information provided, you lack an adequate stability testing program and supporting data to demonstrate that the chemical properties and microbiological attributes of your drug product remain acceptable throughout the labeled expiry period.

The stability test results you provided were limited to color, clarity, odor, and pH. You failed to provide data for identity and strength, impurities, and microbiological attributes (total counts and free of objectionable microorganisms).

Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.

Quality Systems

Your firm’s quality systems are inadequate. 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

If your firm intends to resume manufacturing drugs for the U.S. market, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements before resuming drug manufacturing operations. 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 all CAPAs before you pursue resolution of your firm’s compliance status per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

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 April 15, 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 TCT Nutraceuticals SDN. BHD, FEI 3017270745, at No. 13 Jalan PP11/3 Taman Putra Perdana, Puchong, 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 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 3017270745 and ATTN: Chhaya Shetty

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

 
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