Recipient NameMr. Henry B. Schur
- Red Mountain Inc
676 W. Prospect Rd
Oakland Park, FL 33309
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
4040 North Central Epressway, Suite 300
Dallas, TX 75204-3128
Case # 564578
VIA UPS EXPRESS
Mr. Henry B. Schur - Director
Mr. Joel M. Marcus - Treasurer
Red Mountain Inc.
676 W. Prospect Rd
Oakland Park, FL 33309
Dear Mr. Schur & Mr. Marcus:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Red Mountain Inc., FEI 3011513131, at 676 W. Prospect Rd, Oakland Park, Florida, from October 2 to 11, 2018.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 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 product is 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, based on our review, your product, Bioven, is a misbranded drug under section 503(b) of the FD&C Act, 21 U.S.C. 353(b).
We reviewed your October 30, 2018, response in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish a 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)).
You manufacture finished homeopathic drug products containing ingredients with potentially toxic effects, including snake venom. Oversight is key to ensure drug product safety. You lack quality oversight for the manufacture of your finished homeopathic drug product and you released drug product without an established Quality Unit (QU).
Your management confirmed the lack of a QU and acknowledged that you lack written procedures, including, but not limited to, those procedures governing the responsibilities and functions of the QU. Without an adequate QU, you lack the ability to ensure the safety, identity, strength, quality, and purity of your drug product.
An adequate QU must establish and follow procedures to review and approve all production records. Your quality agreement with your contract manufacturing organization (CMO), (b)(4), requires a certificate of compliance of finished drug product before you release drug product for distribution. However, during the inspection you told our investigator that you examine and monitor temperature when you receive the finished product, but do not sample or approve lots for distribution. Your QU is responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
In addition, when requested on inspection, you were unable to provide supportive documentation that you have qualified your CMO. Your quality agreement explicitly requires that (b)(4) maintain sufficient facilities, resources, and a qualified work force. However, there is a lack of assurance that you hired a CMO capable of manufacturing homeopathic drug products which comply with CGMP.
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/downloads/Drugs/Guidances/UCM070337.pdf.
2. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).
You failed to establish, review, and approve all procedures, including those which may impact the safety, identity, strength, quality, and purity of your drug product. For example, in response to our investigators’ request during the inspection for your established standard operating procedure (SOP), you wrote Procedures for Incoming Bioven Handling, Storage, and Shipping. This procedure was not signed as being reviewed and approved by quality personnel. In addition, you confirmed you did not have any other approved SOPs.
Furthermore, during the inspection your management confirmed that there is no documentation of labelling examination upon receipt or prior to release for use in drug product manufacturing. When asked by our investigator if you had procedures for the receipt, handling, and approval of labels, your management confirmed that you did not have procedures.
Your response to FDA's inspectional observations is inadequate. You provided some new procedures and forms. However, you failed to address the potential effects of the lack of quality unit oversight on the quality and safety of drug product containing potentially toxic ingredients you released to the United States market and which remain within expiry.
In response to this letter, provide the following.
- Your plan for establishing an adequate QU and establishing roles and responsibilities of your QU to assure that your QU will exercise its authority appropriately.
- A comprehensive assessment with corrective and preventive actions (CAPA) to ensure your QU is given the needed authority and resources to effectively discharge its function. The assessment should also include, but not be limited to:
o a determination of whether procedures used by your firm are robust and appropriate;
o provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices;
o complete and final review of each batch and its related information prior to the QU disposition decision; and
o oversight and approval of investigations and discharging of all other QU duties to assure safety, identity, strength, quality, and purity of all products.
- A retrospective evaluation of your homeopathic drug product that remains on the U.S. market within expiry to address any drug product quality or patient safety risks.
o This should include, but not be limited to, establishing your finished product specifications, evaluating whether the drug product you distributed meets those specifications, steps you have taken to investigate any out-of-specification (OOS) results you may identify, as well as any associated corrective and preventative actions.
- Your plans to establish a robust supplier qualification, including a detailed supplier qualification and auditing program that specifies how you ensure that oversight of suppliers is commensurate with risk to finished product.
- Your plans to establish a robust CMO qualification, including a detailed auditing program that specifies how you ensure that your CMO is capable of manufacturing drugs that comply with CGMP and meet all specifications your drug product purports to possess.
- A revised quality agreement which clearly documents which party is responsible for specific activities and how you plan to assure compliance to your quality agreement from all parties involved.
Use of Contract Manufacturers
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of your drugs, regardless of agreements in place with your contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements, at https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf.
CGMP consultant recommended
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the completion and effectiveness 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.
Bioven is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended to diagnose, cure, mitigate, treat, or prevent disease, and/or intended to affect the structure or any function of the body. Claims from the product website, www.bioven.org (which is provided on the product label), that establish the intended use of the product include, but may not be limited to, the following:
- “[I]t has been used by patients with viral infections such as AIDS, Herpes, and some chronic cases of Hepatitis B & C, and even some Cancers.”
- “Bioven works by reversing the body’s chemical and immunological imbalances in illnesses such as Rheumatoid Arthritis, AIDS, Hepatitis B & C, Bursitis, some Cancers and Lupus.”
- “Hepatitis, B & C has been treated, and thus far, has no reportable side effects.”
We recognize that Bioven is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.
We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide entitled, Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the FD&C Act. The CPG states that homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products, such as Bioven, offered for conditions not amenable to OTC use must be marketed as prescription products.
Section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), identifies criteria for determining the prescription status of a product. The above product is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), because in light of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. Therefore, this product is misbranded under section 503(b)(4) of the FD&C Act, 21 U.S.C. 353(b)(4), in that its label fails to bear the symbol, “Rx only.” The introduction or delivery for introduction of these misbranded drugs into interstate commerce is a violation of section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure, and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.
Until these violations are corrected, we may withhold approval of pending drug applications listing your facility. We may re-inspect to verify that you have completed your corrective actions. We may also refuse your requests for export certificates.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Electronically mail a signed copy of your written response to Shawn Larson - Compliance Officer, at Shawn.Larson@fda.hhs.gov and ORAPHARM2_RESPONSES@fda.hhs.gov. Your written notification should refer to Case # 569406.
If you have questions regarding the contents of this letter, you may contact Shawn Larson via phone 214-253-5216 or Shawn.Larson@fda.hhs.gov.
Charles D. Brown
Acting Program Division Director
Office of Pharmaceutical Quality Operations,
 CPG 400.400 states that, in accordance with 503(b)(1) of the FD&C Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, “Caution: Federal law prohibits dispensing without prescription.” This CPG was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended 503(b)(4) of the FD&C Act to require that the label of a prescription drug must bear, at a minimum, the symbol “Rx only.”