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  1. Warning Letters

WARNING LETTER

Sanitizer Supply LLC MARCS-CMS 633583 —

Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Ian Malpass
Recipient Title
President
Sanitizer Supply LLC

2780 Horizon Ridge Court
Suwanee, GA 30024-3569
United States

Issuing Office:
Office of Pharmaceutical Quality Operations, Division II

United States

DATE: September 2, 2022

Case #: 633583

WARNING LETTER

Dear Mr. Malpass:

The U.S. Food and Drug Administration inspected your drug manufacturing facility, Sanitizer Supply LLC, FEI 3017183921, at 2780 Horizon Ridge Court, Suwanee, from March 24 to March 31, 2022.

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 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).

We acknowledge receipt of your April 28, 2022, response to our Form FDA 483. Although you mentioned that you have engaged the services of a consultant and you will cease manufacturing operations, you have not provided specific information or evidence of corrective actions to the observations identified during the inspection on our Form FDA 483.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. 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)).

You manufacture over-the-counter (OTC) drug products including benzalkonium chloride-based (BZK) hand sanitizing wipes and alcohol-based hand sanitizers and repackage hand sanitizer drug products under contract.1 You failed to perform potency and microbial testing for your BZK hand sanitizing wipes prior to release for distribution. You released your BZK hand sanitizing wipes based on a (b)(4). Additionally, in your signed affidavit, you stated that you did not have final product testing results for BZK hand sanitizing wipes.

Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes that are appropriate for their intended use, including microbiological specifications.

2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 (2)).

You failed to test incoming components and active ingredients (e.g., BZK) for identity. This was confirmed in your signed affidavit provided to our investigator. Your firm relied on the certificates of analysis (COA) from unqualified suppliers without establishing the reliability of each of your suppliers’ COA for the component specifications and characteristics.

Identity testing is required for each component lot prior to use in drug product manufacturing, and you can only rely on a COA for other component attributes through validation of supplier’s test results at appropriate intervals.

3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your firm’s quality systems are inadequate. Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to train and ensure that your Customer Service personnel responsible for complaint handling follow your customer complaint procedure. The procedure states that (b)(4). However, during the inspection, your Customer Service personnel told our investigator that they have not received formal training on the procedure, and that they confer with the QU on how to handle complaints. Additionally, your complaint procedure lacked requirements to indicate how the review should be conducted as well as how to classify the severity of complaints.

In addition, in a signed affidavit, you stated that your firm lacks numerous documents applicable to the QU including, but not limited to:

  • Annual Product Reviews
  • CGMP records including training records
  • Stability studies establishing expiration date for BZK hand sanitizing wipes and other drug products, and
  • Master batch records

An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. 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.

Drug Production Ceased

We acknowledge your commitment to cease production of drugs at this facility. However, your firm continues to be registered as a manufacturer. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility or another in the future.

If you plan to resume manufacturing drugs, ensure that adequate corrective actions are in place and notify this office to schedule a meeting before resuming your operations.

Based upon the nature of the violations we identified at your firm, 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. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance, and that the consultant evaluates the completion and efficacy of any identified corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.

Contract Manufacturers

Drugs must be manufactured in conformance with CGMP. The FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. The FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

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 address this matter promptly and adequately 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.

Your written notification should refer to case # 633583.

Please electronically submit your reply, on company letterhead, to Rebecca Asente, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov. In addition, please submit a signed copy of your response to Rebecca.asente@fda.hhs.gov and ORApharm2actingdcb@fda.hhs.gov.

If you have questions regarding the contents of this letter, you may contact Rebecca Asente via (504) 846-8104 or Rebecca.asente@fda.hhs.gov.

Sincerely,
/S/

Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations, Division II

CC:

Nicolas M. Nunez
Executive Vice President
Sanitizer Supply LLC
2780 Horizon Ridge Court
Suwanee, Georgia 30024-3569

James C. Fraser, Regulatory Counsel
Greenberg Traurig LLP
2101 L Street N.W.
Washington D.C. 20037

________________________

1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). This guidance communicated the Agency’s temporary policy that we did not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepared alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances included preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. A review of the formulations of the drug products indicates that such products are not prepared consistent with FDA’s temporary policy set forth in the guidance. Because Sanitizer Supply LLC’s hand sanitizer products are not consistent with the formulations described in these guidances, they do not fall within any temporary Agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act.

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