Inspections, Compliance, Enforcement, and Criminal Investigations

Phillips Co. 5/8/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204

 

May 8, 2017
Ref: 2017-DAL-WL–20
 
WARNING LETTER
 
VIA UNITED PARCEL SERVICE
           
Douglas H. Phillips, Owner
Howard Phillips, LLC.
311 Chickasaw Street
Millerton, Oklahoma 74750
 
Dear Mr. Phillips:
 
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Howard Phillips, LLC dba Phillips Company at 311 Chickasaw Street, Millerton, Oklahoma, from October 4–7, 2016. We also have reviewed your firm’s websites, www.phillipscompany.4T.com and www.diabecline.com. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals observed during the inspection. 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 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, our investigators collected labeling for several products distributed by your firm during the inspection. Based on our inspection and review of your product labeling, including your firm’s websites, FDA has determined that certain products you market and distribute, including, but not limited to, Tetracycline-ABC, Diabecline, TetraStem, and VenomX are unapproved new drugs under Section 505(a) of the FD&C Act 21 U.S.C. 355(a). These products are also misbranded drugs under Section 502 of the FD&C Act 21 U.S.C. 352.
 
We reviewed your October 22, 2016 response to the FDA 483, Inspectional Observations, in detail.
 
During our inspection, our investigator observed specific violations including, but not limited to, the following.
 
CGMP Violations
 
1.    Your firm does not 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 and absence of objectionable microorganisms, prior to release (21 CFR 211.165(a) and (b)).
 
During the inspection, you stated that you do not test any of the topical antiseptic drug products that you manufacture. For example, you distributed Diabecline lot 61111 on September 6 and September 29, 2016, and Tetracycline-ABC lot 511110 on October 13, 2016, without testing. Specifically, you did not test these lots for chemical attributes, including identity and strength of each active ingredient. 
 
In addition, your firm lacked testing for microbial attributes, including absence of objectionable microorganisms, or sterility, where appropriate. We note that your topical antiseptic drug products are indicated for use on injured skin, minor cuts, scrapes, and burns. It is essential that your drug products are tested for appropriate microbial attributes in view of their intended uses. 
 
2.    Your firm failed to use equipment constructed to ensure surfaces that contact components, in-process materials, or drug products are not reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirement (21 CFR 211.65(a)).
 
Our investigator observed bulk drug products stored in repurposed household containers, such as bottles for plastic soft drinks, juice, milk, and cleaning agent. For example, we found that you used a repurposed home cleaning agent spray bottle to store bulk StaphWash. This home cleaning agent contains ingredients such as sodium percarbonate and hydrogen peroxide.
 
You market your StaphWash as a protectant for “injured and exposed skin or mucous membrane surfaces.” Your storage practices elevate the risk that drug products might contain potentially harmful contaminants. Applied to the skin, these contaminants can be hazardous to patients.
 
3.    Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
 
During the inspection, we found that your firm lacked critical procedures to ensure a functional quality unit including, but not limited to, procedures for establishing specifications, review and approval of investigations, complaint handling, and change management.
 
For example, you stated that you do not have specifications for your drug products because you frequently alter formulations during manufacturing. Given your poor manufacturing practices, there is substantial potential for production of inconsistent and poor-quality drug products. It is imperative that drug products be consistently manufactured to ensure each batch meets appropriate quality standards and specifications.
 
We also observed your failure to establish adequate written quality control unit responsibilities during our August 2016 inspection.
 
4.    Your firm failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(2)). 
 
You have not tested incoming active pharmaceutical ingredients or other components you use in manufacturing to determine their identity, purity, strength, and other appropriate quality attributes. For example, during the inspection, you stated that your incoming material testing was limited to color, odor, and “a mixing comparison.”
 
5.    Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
 
You have not specified or validated manufacturing processes to ensure reproducible batch quality. For example, your procedures for filling and hold times do not include defined process parameters such as mixing times, blending speeds, and bulk hold times. In addition, our investigator noted that you use a household kitchen blender to mix ingredients.
 
Our findings demonstrate a lack of understanding of the basic elements of a compliant manufacturing operation, such as suitable facilities and equipment, trained personnel, appropriate components, a well-defined process, and written procedures. These and other elements supporting process validation are outlined in FDA’s guidance document, Process Validation: General Principles and Practices, available at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf.
 
6.    Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
 
Your firm lacked complete batch records for all drug products you manufacture. For example, you were unable to locate the batch record for a distributed batch of Tetracycline-ABC, lot 511110. Batch records that you were able to locate were incomplete, as they lacked critical information regarding bulk processing, filling, and packaging operations that establish whether the manufacturing process was followed and is reproducible.
 
During our August 2016 inspection, we also noted your failure to adequately prepare and maintain batch records for drug products you manufacture.
 
Unapproved New Drug Violations
 
You market Tetracycline-ABC, Diabecline, TetraStem, and VenomX via your websites with claims to diagnose, cure, mitigate, treat or prevent disease and/or to affect the structure or function of the body. Based on labeling claims, these products 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 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 of man.
 
The intended use of a product may be determined by, among other things, its labeling claims, advertising, and circumstances surrounding its distribution. See 21 CFR 201.128. We reviewed your websites and statements documenting the intended use of your above listed products include, but are not limited to, the following.
 
Tetracycline-ABC
  • The product label for Tetracycline-ABC (TABC) represents the product as an antimicrobial antiseptic with the active ingredient tetracycline 3%. 
Your website www.phillipscompany.4t.com/cc.pdf states:
  • “It kills the most drug-resistant and the most deadly bacteria (MRSA and Acinetaobactoer)”
  • “Kills MRSA, Staph (Staphylococcus aureus), Acinetobacter baumannii, Acinetobacter lwoffi, Klebsiella pneumoniae, E. coli, Proteus vulgaris, Pseudomonas aeruginosa, Enterobacter cloacae, and Group-A strep.”
  • “TABC shown to be effective against toenail fungi”
  • “Tet-ABC—Inhibits fungus growth, but not as well as Tetra-ABC”
  • “Tetracycline is a broad-spectrum polyketide antibiotic produced by the Streptomyces genus of Actinobacteria, indicated for use against many bacterial infections…It is commonly used to treat acne today, and more recently, rosacea, and played a historical role in stamping out cholera in the developed world”
Your website www.phillipscompany.4t.com/DI.pdf states:
  • “Necro Biosis Lipoidica Diabeticorum (NLD) treated with Tetra formulation” 
Diabecline
  • The product label for Diabecline represents the product as an antimicrobial antiseptic with the active ingredient tetracycline 3%.
Your website www.phillipscompany.4t.com/DI.pdf states:
  • “Rapid reversal of the onset of blood poisoning”
  • “I have also found DiabeclineTM antibiotic to be effective in the treatment and healing of serious, deep wounds resulting from diabetic foot syndrome”
  • “This is because it now shows that Diabecline and TETRA-ABC may heal what appears to be dead necrotic tissue”
  • “BEFORE Severe canine leg wound; MRSA infected. AFTER Healed, including the regrowth of tendon, muscle, skin and fur.”
Your website www.phillipscompany.4t.com/miranda.pdf states:
  • “With only a TOPICAL (rub-it-on-the-skin) formula, it is now possible to successfully induce stem cell therapy to treat spinal cord injury and dramatically reduce paralysis”
  • “Our other miracle product, “Diabecline” can prevent amputations (which occur as a result of Diabetes Type-2 lesions) in many Diabetic ulcer/lesion cases.” 
TetraStem
  • The product label for TetraStem (TS) represents the product as an antimicrobial antiseptic with the active ingredient tetracycline 3%.
Your website www.phillipscompany.4t.com/miranda.pdf states:
  • “Spinal cord injury treated with TetraStem”
  • “With only a TOPICAL (rub-it-on-the-skin) formula, it is now possible to successfully induce stem cell therapy to treat spinal cord injury and dramatically reduce paralysis”
  • “Another reason for 24/7 treatment with TS is there will be no infection while TS is used. In a hospital, there is always the threat of HA MRSA or a HA Staph infection. We KNOW that TS is an excellent post-surgical prevention of infection”
  • “TetraStem can induce stem-cell healing”
  • “Tetracycline is incorporated into mineralizing bone and can be detected by its fluorescence. This ability of tetracycline is believed to have been responsible for the rapid healing of the bone fractures in Miranda’s neck vertebrae.”
  • “To treat muscle atrophy, TetraStem was also applied to Miranda’s legs and arms beginning the last week in August”
VenomX
  • The product label for VenomX represents the product as a skin protectant with the active ingredient zinc acetate 0.1 % by volume.
Your website www.phillipscompany.4t.com/VXFT.pdf states:
  • “VenomX was in development for 5 years, including field testing with human snake bite victims.”
  • “Because of the promise of using our skin cleanser to attack, neutralize and remove toxins from insect bites and stings, we believed the same benefit could result from the use of this cleanser immediately following a snakebite incident.”
  • “VenomX is an anti-venom cleanser formulated to chemically attack and dissolve the snake venom rapidly, rendering it less harmful.”
  • “When I used VenomX, I didn’t have the swelling that typically follows a snakebite; I didn’t go to the hospital. After using VenomX, the burning sensation eased up within a few minutes.”
  • “I began applying the VenomX within a couple of minutes…I used a toothpick to massage the anti-venom into the puncture hole made by the fang…The symptoms began to go away within minutes after the treatment…I felt like I didn’t need to go to the hospital.”
Tetracycline-ABC, Diabecline, TetraStem, and VenomX are also “new drugs” as defined by Section 201(p) of the FD&C Act 21 U.S.C. 321(p) because they are not generally recognized as safe and effective for the above referenced uses, nor are your products marketed in conformity with any over-the-counter (OTC) Drug Monograph.
 
Under Section 505(a) of the FD&C Act, a new drug may not be legally marketed in the United States without an FDA-approved application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. (b)(4). Thus, the marketing and distribution of these products for their intended uses violate this provision of the FD&C Act. The introduction of an unapproved new drug into interstate commerce is a violation of Section 301(d) of the FD&C Act 21 U.S.C. 331(d).
 
Misbranded Drug Violations
 
Because Tetracycline-ABC, Diabecline, TetraStem, and VenomX are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus your products’ labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under Section 502(f)(1) of the FD&C Act 21 U.S.C. 352(f)(1). The introduction or delivery for introduction of misbranded drugs into interstate commerce violates Section 301(a) of the FD&C Act 21 U.S.C. 331(a).
 
Inadequate Response and Your Commitment to (b)(4)
 
You distributed multiple lots of drug products, despite the serious violations noted above. In your response, you acknowledged that your “ability to build a pharmaceutical manufacturing company has been found lacking, as shown by the FDA inspection report.” Your response to FDA’s inspectional observations is inadequate. It does not address the specific CGMP deficiencies identified during this inspection. Your response also stated that you “plan to (b)(4)” and “(b)(4).” However, you note that you will not (b)(4) undetermined drug product.
 
During FDA’s 2009 inspection of your firm, you similarly stated that you would (b)(4) your drug products. However, you subsequently (b)(4).
 
If you are considering (b)(4) now or in the future, you should immediately contact the District office and provide your proposed plan to (b)(4). The plan should describe the actions you will be taking to bring your facility into compliance prior to (b)(4).
 
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 in the event you (b)(4). Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm's executive management will remain responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance.
 
Concerning the drugs that you have distributed, you should specify actions you will take, such as notifying customers and recalling products.
 
Additionally, your firm’s response indicates your firm intends to continue to distribute products for (b)(4). Your drugs as formulated and labeled are unapproved new drugs under Section 505(a) the FD&C Act, 21 U.S.C. 355(a). (b)(4).
 
Conclusion
 
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 in all your facilities and websites.
 
You must 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.
 
If you have any questions about this letter, contact Jeff Wooley, Compliance Officer, at 214-253-5251. Send your response to:
 
Dallas District Office
4040 N. Central Expressway
Suite 300
Dallas, TX 75204
 
Please identify your response with FEI 3006899835 and 2017-DAL-WL-20.
                                                                                    
Sincerely,
/S/ 
Shari Shambaugh
Acting Dallas District Director
 

Page Last Updated: 05/15/2017
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