Inspections, Compliance, Enforcement, and Criminal Investigations

West Coast Laboratories Inc 9/15/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 15, 2014                                                                                       
W/L# 35-14
 
Mr. Maurice E. Ovadia, President/Owner
Mr. Ronnie E. Ovadia, Technical Director
West Coast Laboratories, Inc.
116 E. Alondra Blvd.
Gardena, CA 90248-2806
 
Dear Mr. Maurice E. Ovadia and Mr. Ronnie E. Ovadia,
 
On February 4–18, 2014, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 116 E. Alondra Blvd., Gardena, California. Based on our inspection and subsequent review of your product labeling collected during the inspection, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and the FDA regulations through links on FDA’s home page at www.fda.gov.
 
Your response to the FDA 483, Inspectional Observations, was received on March 18, 2014. Our assessment of your response follows each violation noted below.
 
Unapproved New Drugs
 
FDA laboratory analyses confirmed the presence of the following undeclared active pharmaceutical ingredients (APIs) in certain products that you manufacture, as identified below:
 

Product Name
Undeclared API(s)
Super ArthGold
chlorzoxazone, indomethacin, and piroxicam
Pro ArthMax
chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and nefopam

 
Chlorzoxazone is the API in the FDA-approved drug Parafon Forte® DSC, approved on August 15, 1958, and is a prescription drug used to relieve musculoskeletal pain. Diclofenac, indomethacin, ibuprofen, piroxicam, and naproxen are non-steroidal anti-inflammatory drugs (NSAIDs) and APIs found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions, including some arthritic conditions.[1] Nefopam is a non-opioid analgesic and is not approved for use in the United States. 
 
Your “Super ArthGold” and “Pro ArthMax” products are marketed as dietary supplements. Under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement may not contain an article that is approved as a new drug under section 505(a) of the Act [21 U.S.C. § 355(a)] unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug.  Given that neither chlorzoxazone, diclofenac, indomethacin, ibuprofen, piroxicam, nor naproxen were marketed as dietary supplements or as foods before FDA’s approval of Parafon Forte® DSC, Voltaren®, Indocin®, Motrin®, Feldene®, and Naprosyn®, your “Super ArthGold” and “Pro ArthMax”[2] are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act.
 
Moreover, your products are drugs as defined by section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] because they are intended to affect the structure or function of the body. Labeling statements documenting the intended use of your products as drugs include, but are not limited to the following:
 
“Pro ArthMax”
  • “Promotes healthy joints & cartilage”
  • “Better Performance . . . Better Flexibility . . . Better Mobility”
  • “With Pro ArthMax, they could work better, move better, and feel better.”
 “Super Arthgold”
  • “Super Arthgold is an ‘All-Natural Source Formula’ that has been known to help with    arthritis, joint, and muscle-related aches and pains.”
  • “Super Arthgold may improve the blood circulation, which can help relieve soreness caused by lactic acid build-up in the muscle tissues. Better blood flow can also contribute to increased range of motion in the joints, which may help arthritis and joint pain.”
 
Furthermore, FDA analysis of your “HerbAid Powder” blend confirmed the presence of undisclosed APIs in this ingredient. These undeclared APIs include chlorzoxazone, indomethacin, diclofenac, piroxicam, naproxen, ibuprofen, and/or nefopam. Under section 201(g)(1)(D) of the Act [21 U.S.C. § 321(g)(1)(D)], an article intended for use as a component of a drug is also a drug. Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. See Title 21 of the Code of Federal Regulations, Part 210.3(b)(3) [21 CFR 210.3(b)(3)]. Manufacturing batch records obtained from your firm indicate that “HerbAid Powder” is an ingredient used in the manufacture of drugs, including, but not limited to, “Super ArthGold” and “Pro ArthMax” products. Accordingly, your “HerbAid Powder” blend is a drug within the meaning of section 201(g)(1)(D) of the Act [21 U.S.C. § 321(g)(1)(D)]. 
 
Moreover, your “Super ArthGold” and “Pro ArthMax”  products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for it. There are no FDA-approved applications on file for “Super ArthGold” and “Pro ArthMax.” The distribution or sale of such products without approved applications violates these provisions of the Act.
 
Misbranded Drugs
 
Your “Super ArthGold” and “Pro ArthMax” products contain one or more muscle relaxants, NSAIDS, and/or drugs not approved for marketing in the United States. Specifically, chlorzoxazone, piroxicam, diclofenac, and indomethacin are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs. Therefore, your “Super ArthGold” and “Pro ArthMax” products are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potentiality for harmful effect, the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. 
 
As such, your “Super ArthGold” and “Pro ArthMax” products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because their labeling fail to bear adequate directions for their intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because there are no FDA-approved applications for your firm’s “Super ArthGold” and “Pro ArthMax” products, their labeling fail to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
 
Under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. According to section 201(n) of the Act [21 U.S.C. § 321(n)], in determining whether the labeling or advertising “is misleading, there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations . . ..” The use of muscle relaxants, NSAIDs, and other pain relieving drugs not approved for use in the United States can be associated with significant safety issues and the risk of serious adverse events. The undeclared drugs in your products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage including bleeding, ulceration, and fatal perforation of the stomach and intestines. Chlorzoxazone is a muscle relaxant which may cause drowsiness, dizziness, and lightheadedness, which may impair the ability to perform certain tasks, such as driving a motor vehicle or operating machinery. Because Nefopam is not FDA-approved, safety or efficacy has not been established for this non-narcotic pain relieving drug. In literature, adverse events such as rapid heart rate, sweating, dizziness, confusion, hallucinations, and seizures have been reported with Nefopam. Accordingly, your “Super ArthGold” and “Pro ArthMax” products are misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)] because their labeling is false or misleading in that it fails to reveal material facts with respect to consequences that may result from the use of these products.
 
Your “Super ArthGold” and “Pro ArthMax” products are also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the products’ labeling lack adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of the undisclosed drugs contained in these products. Consumers who use these products would be unaware of the presence of the undeclared muscle relaxants, NSAIDS, and/or other pain relieving drugs and placed at risk for their associated adverse events. 
 
Accordingly, the introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Dietary Supplement Current Good Manufacturing Practice (CGMP) Violations
 
With respect to your dietary supplement products, our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR part 111). These violations cause your dietary supplements including, but not limited to, “Nano Cal/Mag” (capsules), “Lipozene” (capsules), “Metabo Up Plus” (tablets) and “Prenatal Formula with Folic Acid” (capsules) products, to be adulterated within the meaning of section 402 (g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342 (g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
 
Specific violations observed during the inspection include, but are not limited to, the following:
 
1.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm did not perform any testing to verify the identity of the raw materials used in the manufacturing of your dietary supplements. For example, you did not conduct identity testing for the following dietary ingredients:
 
a.    Amorphophallus Konjac Root used in the manufacturing of “Lipozene” capsules (lots (b)(4));
 
b.    Green Tea Powder Extract, Guarana Powder Extract, Sterilized Oolong Tea Powder, Kola Nut Powder Extract, Cayenne Pepper Powder, Platycodon Root 10-1 Powder Extract, Cyanocobalamin 1% Trituration, Vitamin B-6, Caffeine Anhydrous Powder, and MetaboUp Blend used in the manufacturing of “MetaboUp Plus” tablets (lots (b)(4));
 
c.    Manganese, Copper, Zinc, Magnesium, Potassium, Iodine, Iron, Niacinamide Granular, Vitamin A Palmitate, Vitamin D, Thiamine Mononitrate, Riboflavin Powder, Vitamin B-6, Folic Acid, Cyanocobalamin, Calcium, and Ascorbic Acid used in the manufacturing of “Prenatal with Folic Acid” tablets (lots (b)(4));
 
d.    Nano Cal/Mag Powder blend used in the manufacturing of “Nano Cal/Mag”  capsules (lot (b)(4)).
 
We acknowledge in your response dated March 3, 2014, you stated that you are sending  raw materials to a lab in (b)(6), CA for identity analysis. Our review of your response determined that it is inadequate because you failed to provide adequate evidence that you are effectively implementing the corrective action. Specifically, you did not provide any verification documents from the lab of the type of testing they are conducting and the materials tested.
 
2.    Your firm failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificate of analysis through confirmation of the results of the suppliers’ test or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, you told investigators that you rely on certificates of analysis provided by your suppliers without performing any verification testing. In addition, please note that you are also required to maintain documentation of how you qualified a supplier pursuant to 21 CFR 111.75(a)(2)(ii)(C).
 
We acknowledge in your response dated March 3, 2014, you indicated that you are in the process of performing written audits of all of your vendors, chemical assays of their ingredients to qualify them, and that you have written an SOP for this procedure. However, our review determined your response is inadequate because you failed to provide supporting documents of your corrections and established procedures. Specifically, your firm failed to provide sufficient detail on how vendors are qualified and it did not address the immediate concern of using vendors that are not qualified.   
 
3.    Your firm failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by  21 CFR 111.70(a). Specifically,
 
a.    You failed to establish specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplements for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
 
b.    You failed to establish specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement, as required by 21 CFR 111.70(e.)
 
Once you have established the above specifications, you must determine whether the established specifications are met in accordance with 21 CFR111.73, and you must make and keep records in accordance with 21 CFR 111.95(b).
 
We acknowledge in your response dated March 3, 2014, you indicated that you will purchase raw material standards and establish raw material specifications for each ingredient you use; and that you began establishing specifications for finished products. However, your response is inadequate because you failed to provide supporting documentation of your corrections and established specifications. 
 
4.    Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, you do not have written procedures for the responsibilities of your quality control operations pertaining to the following areas:
 
a.    Component, packaging, and labels before use in the manufacture of a dietary supplement [21 CFR 111.120];
 
b.    Master manufacturing record, batch production record, and manufacturing operations [21 CF 111.123];
 
c.    Packaging and labeling operations [21 CFR 111.127].
 
We acknowledge in your response dated March 3, 2014, you indicated that you expect to hire a Quality Control employee and are in the process of creating SOPs. However, our review determined your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
5.    Your firm did not prepare a written master manufacturing record (MMR) that establishes controls and procedures to ensure that each batch of a dietary supplement that you manufacture meets specifications, as required by 21 CFR 111.205(b)(2). Specifically,  your firm’s MMR for the “Nano Cal/Mag” capsules, “Lipozene” capsules, “MetaboUp Plus” tablets, and “Prenatal with Folic Acid” tablets did not include the following required information:
 
a.    A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition is made [21 CFR 111.210(f)]. Your MMRs list a statement of the theoretical yield expected at the end of batch production; however, they do not include the maximum and minimum percentages of theoretical yield beyond which a deviation investigation is necessary;
 
b.    A description of packaging [21 CFR 111.210(g)];
 
c.    Written procedures for sampling and a  cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
 
d.    Written corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
 
We acknowledge in your response dated March 3, 2014, you indicated that you in the process of revising all of your batch records. However, our review determined your response is inadequate. Your response did not address your master manufacturing records.
 
6.    Your firm’s batch production record (BPR) did not include complete information relating to the production and control of each batch of dietary supplements, as required by 21 CFR 111.255(b). Specifically, your firm’s BPR for the “Nano Cal/Mag” capsules, “Lipozene” capsules, “MetaboUp Plus” tablets, and “Prenatal with Folic Acid” tablets did not include the following required information:
 
a.    The identity of equipment and processing lines used in the producing the batch [21 CFR 111.260(b)];
 
b.    The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in the producing the batch, or a cross-reference to records such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
 
c.    A statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
 
d.    The actual results obtained during any monitoring operations [21 CFR 111.260(g)];
 
e.    The unique identifier you assigned to each packaging material used, and the quantities used [21 CFR 111.260(k)(1)];
 
f.    An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)];
 
g.    Documentation that quality control personnel reviewed the BPR [21 CFR 111.260(l)(1)];
 
h.    Documentation that quality control personnel approved and released, or rejected, the batch for distribution [21 CFR 111.260(l)(3)].
 
We acknowledge in your response dated March 3, 2014, you indicated that you are in the process of developing the identification of machinery, dates and times, cleaning logs, and maintenance logs. However, our review determined your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
7.    Your firm failed to comply with the requirements for reserved samples that are established by 21 CFR 111.83. Specifically, for each lot of packaged and labeled dietary supplements that you distribute, you did not specify the sample size for reserve samples to ensure that they consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications [21 CFR 111.83(b)(4)].
 
We acknowledge in your response dated March 3, 2014, you indicated that you are writing a new SOP for collecting representative samples from multiple points of production. However, our review determined your response is inadequate because you failed to provide supporting documentation of your corrections and established procedures.
 
8.    Your firm failed to document at the time of performance that established laboratory methodology was followed as required by 21 CFR 111.325(b)(2)(i). Specifically, your firm conducts disintegration testing for your finished dietary supplement products; however, the only record related to this test is a Laboratory Control Report that lists the disintegration time results. There is no documentation of the following test parameters: (1) the quantity of sample tested; (2) the temperature of the immersion fluid; and (3) the date of the analysis.
 
We acknowledge in your response dated March 3, 2014, you indicated that you are developing documentation forms for laboratory tests performed. However, our review determined your response is inadequate in that your firm has not provided sufficient evidence that you have written and implemented a new SOP to address this deviation. Also, your firm failed to provide sufficient evidence that documentation forms are developed and implemented to address this deviation.
 
9.    Your firm did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement to ensure the accuracy and precision of the instruments or controls as required by 21 CFR 111.27(b). Specifically, your firm has not calibrated the thermometer used to measure the water temperature during disintegration testing of finished dietary supplement products for at least 3 years. As such, there is no assurance that the analysis was performed under the (b)(4) temperature range established in the procedure.
 
We acknowledge in your response dated March 3, 2014, you indicated that you are contracting with an outside thermometer calibration company to calibrate your thermometers on an annual basis. Our review determined your response is inadequate in that your firm did not provide supporting documentation to demonstrate that you hired an outside thermometer calibration to address this violation.
 
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. 
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
 
If you have any questions regarding this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918
 
Your written reply should be sent to:
Acting Director
Compliance Branch
US Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2446
 
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District Director
 
 
cc:        Harlan Loui
            Branch Chief, Food and Drug Branch
            California Department of Public Health
            1500 Capitol Ave. ~MS 7602
            P.O. Box 997413
            Sacramento, CA 95899-7413


[1] Diclofenac is the API in the FDA-approved drug Voltaren®, approved on July 28, 1988; indomethacin is the API in the FDA-approved drug Indocin®, approved on June 10, 1965; ibuprofen is the API in the FDA-approved drug Motrin®, approved on September 19, 1974; piroxicam is the API in the FDA-approved drug Feldene®, approved on April 6, 1982; and naproxen is the API in the FDA-approved drug Naprosyn®, approved on March 11, 1976.
 
[2] We note that you also manufacture “New ProArth Max” and bulk label the product as a “food supplement” for further processing by an own label distributor. This product, which appears to be a substantially similar or subsequent version of “ProArthMax,” was analyzed by FDA and determined to contain undeclared drug ingredients including, chlorzoxazone, indomethacin, and piroxicam. Accordingly, “New ProArthMax” is excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act.

Page Last Updated: 04/27/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.