Salon Technologies International, Inc. MARCS-CMS 630566 —
- Delivery Method:
- VIA Electronic Mail
Recipient NameMr. Ted Khoury
- Salon Technologies International, Inc.
8810 Commodity Circle, Suite 20
Orlando, FL 32819
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
Case #: 630566
Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as Salon Technologies International Sanitizing Hand Spray 80%. Your firm also provided impurity test results for a consumer hand sanitizer, labeled as Antica Farmacista Hand Sanitizer Ocean Citron. These drug products were manufactured at your facility, Salon Technologies International, Inc., at 8810 Commodity Circle, Suite 20, Orlando, FL, and distributed in the United States.
The results of the FDA laboratory testing, and tests results provided by your firm, of batches of these products in U.S. distribution demonstrate that these drug products manufactured at your facility are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug & Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B))1, in that contamination with unacceptable levels of impurities demonstrate that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
Salon Technologies International Sanitizing Hand Spray 80% was manufactured at your facility. FDA laboratory testing of a batch of this product in U.S. distribution, found that the drug product contained impurities at unacceptable levels.1 Acetaldehyde and acetal impurities were found to be approximately 739 parts per million (ppm) and 988 ppm, respectively.
Acetaldehyde and acetal are known impurities of alcohol, as delineated in the United States Pharmacopeia (USP). The USP monograph for alcohol limits acetaldehyde and acetal to not more than (NMT) 10uL/L, 10 ppm (expressed as acetaldehyde). Alcohol not meeting the specification for acetaldehyde and acetal is deemed adulterated under section 501(b) of the Act. Alcohol represents a significant component of your drug product; therefore, you must have a specification for acetaldehyde and acetal per 21 CFR 211.160(b). Further, finished product testing of each batch of drug product is required under 21 CFR 211.165. The test results for acetaldehyde and acetal impurities in your drug products are unacceptable because these results are higher than the levels expected if the alcohol contained in your products complied with compendial standards and if you had conducted finished product testing with a specification for acetaldehyde and acetal. Therefore, your drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act.
Acetaldehyde appears to be genotoxic, and potentially carcinogenic, when in direct contact with tissues.
On June 24, 2022, FDA sent you a letter informing you of the unacceptable levels of impurities2 in your Salon Technologies International Sanitizing Hand Spray 80% and requested additional information, including impurity testing of retain samples to determine the quality of all batches of hand sanitizer drug products distributed in the United States within expiry.
On September 2, 2022, your firm provided impurity test results from retain samples, which included your Antica Farmacista Hand Sanitizer Ocean Citron drug product. Your test results for a batch of this drug product manufactured at your facility demonstrate that the drug product contained impurities at unacceptable levels. As reported by your firm, benzene impurity levels were found to be approximately 12 ppm.
Manufacturers should not use benzene in the manufacture of drugs because it is a known human carcinogen that causes leukemia and other blood disorders. FDA has alerted all drug manufacturers to the known risk factors for contamination with benzene. For more information see https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs.
On September 14, 2022, FDA held a teleconference with you. We recommended you consider removing the adulterated batches of Salon Technologies International Sanitizing Hand Spray 80% and Antica Farmacista Hand Sanitizer Ocean Citron currently in distribution from the U.S. market. On September 17, 2022, you issued a voluntary nationwide recall of one lot of your Salon Technologies International Sanitizing Hand Spray 80% due to the presence of acetaldehyde and acetal impurities and one lot of your Antica Farmacista Hand Sanitizer Ocean Citron due to the presence of benzene impurities.
Your firm failed to conduct impurity testing, including acetal, acetaldehyde, and benzene, of active pharmaceutical ingredients or for your finished hand sanitizer drug products prior to distribution. Because these impurities are a known risk of the manufacturing process, a finished product specification for these impurities in hand sanitizers is appropriate under 21 CFR 211.160(b). Further, finished product testing of each batch of drug product is required under 21 CFR 211.165.
The contamination with benzene, acetaldehyde, and acetal impurities in drug products manufactured in your facility, in addition to your failure to conduct impurity testing of your drug products prior to distribution, demonstrate that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.
On October 6, 2022, FDA notified the public of the unacceptable impurity results in your hand sanitizer drugs products at the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
In response to this letter, provide:
- A detailed investigation into how the hand sanitizer drug product described above, which was manufactured at your facility contained unacceptable levels of impurities.
- A list of all raw materials used to manufacture your hand sanitizer drug products, including the suppliers’ names, addresses, and contact information.
- Copies of the complete batch records for all batches distributed to the United States.
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 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 audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of any identified corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
The violations cited in this letter are not intended to be an all-inclusive list of violations associated with your drug products. 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 inspect to verify that you have completed corrective actions to address any violations.
If you decide you want to manufacture drugs for the United States in the future, request a Regulatory Meeting to discuss corrective actions.
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 do so within 15 working days, state your reasons for delay and your schedule for completion.
Your written notification should refer to case # 630566.
Please electronically submit your reply, on company letterhead, to Shawn Larson, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov. In addition, please submit a signed copy of your response to Shawn.Larson@fda.hhs.gov and Ronda.Loyd-Jones@fda.hhs.gov.
If you have questions regarding the contents of this letter, you may contact Shawn Larson via phone at 214-253-5216 or email at Shawn.Larson@fda.hhs.gov.
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations, Division II
1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, the 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. Because Salon Technologies LLC hand sanitizer drug products were not consistent with the formulations described in these guidances, they did 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.
2 In the June 24, 2022 letter, FDA had described “unacceptable” levels of acetal and acetaldehyde as being above 50 ppm. That number had originally been described in the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), and had represented FDA’s intent to not take action against products within that level of impurity, provided that the other circumstances described in the guidance were present. As noted in FN1 above, that temporary policy has been withdrawn, and accordingly acetal and acetaldehyde levels in alcohol must not exceed the 10 ppm limit prescribed by the USP.