WARNING LETTER
Atlanta Supersource, Inc.
MARCS-CMS 693399 —
January 08, 2025
Delivery Method:
VIA Electronic Mail
Reference #:
320-25-29
Product:
Drugs
Recipient:
Recipient Name
Mr. David M. Rose
Recipient Title
CEO and Co-Owner
Atlanta Supersource, Inc.
3655 Kennesaw 75 Parkway NW, Suite 100
Kennesaw
,
GA
30144-6502
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-25-29
January 8, 2025
Dear Mr. Rose:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Atlanta Supersource, Inc., FEI 3016837288, located at 3655 Kennesaw 75 Parkway NW, Suite 100, Kennesaw from July 15 to 19, 2024.
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).
In addition, INSTANT HAND SANITIZER Rinse-Free Gel and INSTANT HAND SANITIZER Rinse-Free Foam are misbranded under sections 502(a) of the FD&C Act, 21 U.S.C. 352(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
We acknowledge receipt of your response to our Form FDA 483. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
CGMP Violations
1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
Your firm manufactures topical over the counter (OTC) hand sanitizer drug products. You also manufacture commercial industrial chemical products, labeled with warnings such as “cause severe skin burns” and “may cause allergic skin reactions,” on the same manufacturing equipment as your OTC drug products.
It is unacceptable as a matter of CGMP to manufacture drugs using the same equipment that you use to manufacture these toxic industrial grade products due to the risk of cross-contamination.
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)).
Your firm failed to adequately test your drug products for the identity and strength of the active ingredient, benzalkonium chloride (BZK), prior to release and distribution.
Full release testing, including for identity and strength must be performed prior to batch 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 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 conduct an identity test on each shipment of each lot of components used in the manufacture of your drug products, (e.g., BZK,
(b)(4)
). You also failed to determine whether each component conformed with all appropriate written specifications for purity, strength, and quality before using them.
Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products.
Additionally, your firm uses water as a component in your drug products. Your water system is not adequately monitored to ensure that it can produce water that meets United States Pharmacopeia (USP) purified water monograph specifications.
Water for pharmaceutical purposes must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.
Misbranding Violations
“SuperSource INSTANT HAND SANITIZER Rinse Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” 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 “SuperSource INSTANT HAND SANITIZER Rinse-Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” product label provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:
“SuperSource INSTANT HAND SANITIZER Rinse Free Gel”
“Uses: may help reduce bacteria that potentially can cause disease.” [from product label]
“SuperSource INSTANT HAND SANITIZER Rinse-Free Foam”
“Uses: may help reduce bacteria that potentially can cause disease.” [from product label]
The labeling for such drugs, like all OTC drugs, must comply with all of the requirements of section 502 of the FD&C Act and all pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR).
However, “SuperSource INSTANT HAND SANITIZER Rinse Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the products’ labels include the statement “MADE IN AN FDA REGISTERED FACILITY” and the acronym “FDA” in the statement is in a form that is similar to the FDA logo. FDA’s regulations provide that “[r]egistration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed” (21 CFR 207.77(a)). However, the general public is not likely to be familiar with the details of FDA’s regulations. The assertion that your products were “Made in an FDA Registered Facility,” have an “Approved FDA formulation,” combined with your use of the acronym FDA in a form that is similar to the FDA logo on a product label misleadingly suggests that the drug products are approved or endorsed by FDA in some way. Your “SuperSource INSTANT HAND SANITIZER Rinse Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” products are not the subjects of an FDA-approved application. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading.
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).
Cosmetics Manufactured for Distribution in the United States
In addition, we note that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. Under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.
Further, your facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Information on MoCRA requirements may be found at
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.
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
We acknowledge your commitment to “discontinue production of all hand sanitizer (products regulated by the FDA).” However, as of the date of this letter, your website at https://supersourceinc.com/market-segments/#rs includes a statement that promotes the sale of hand sanitizer, “We provide several products for the equipment, and hand sanitizers to keep employees clean.” Additionally, your website at https://supersourceinc.com/products-chemicals/ includes a product listing and image promoting “Hand Sanitizer.” In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility or any other facility in the future.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. Based upon the nature of the violations we identified at your firm, if you resume manufacturing drugs 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. 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.
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 3016837288 and ATTN: Joel Hustedt.
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
Content current as of:
01/21/2025
Regulated Product(s)
Drugs