Inspections, Compliance, Enforcement, and Criminal Investigations
Atlantic Pro Nutrients, Inc. dba XYMOGEN 12/13/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
December 13, 2011
Mr. Brian J. Blackburn, CEO
Atlantic Pro Nutrients, Inc.
725 S. Kirkman Road
Orlando, FL 32811-2011
Dear Mr. Blackburn:
The Food and Drug Administration (FDA) conducted an inspection of your dietary supplement labeling and distribution facility located in Orlando, Florida, at the above referenced address, from July 18, to August 1, 2011. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional Observations, which listed a number of the violations that cause your dietary supplement 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)] because they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements.
Your significant violations of the dietary supplement CGMP requirements are as follows:
- You have not identified who is responsible for your quality control operations (each person who is identified must be qualified to perform quality control operations and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has), as required by 21 CFR 111.12(b). Specifically, at the time of the inspection you had not identified the employees specifically responsible for your quality control operations.
In your response letter dated August 19, 2011, you include a biography of yourself (Mr. Blackburn) and further state you have appointed “qualified personnel [both outside consultants and XYMOGEN employees] to establish and institute SOP’s and policies designed to comply with current FDA regulations.” While you may be taking appropriate steps with regard to addressing your lack of SOPs and compliance with CGMP regulations, you have not specifically identified who is responsible for your quality control operations; thus, we find your response inadequate.
- You did not have qualified personnel review all product complaints and did not have your quality control personnel review and approve decisions about whether to investigate a product complaint, as required by 21 CFR 111.560(a) and (b). Specifically, your current practice of customer service representatives receiving complaints and escalating them “if they deem serious” is inadequate in that you have not designated these customer service representatives as quality control personnel who are qualified to review and make approval decisions about whether to investigate a product complaint. In addition, you did not make and keep records for product complaints as required under 21 CFR 111.570(b)(2).
In your response letter dated August 19, 2011, you state your product complaint system allows “all complaints to be logged into an (b)(4) database and categorized by type.” We also note that you included SOP R-001 Customer Complaint Records in addressing this observation. Your response fails to demonstrate that your product complaint system meets the requirements of 21 CFR 111.560. Specifically, your response does not provide specific information regarding how a product complaint will be investigated and fails to identify how you have “qualified” the personnel whom are reviewing each complaint. Moreover, your written response does not adequately address what records you will make and keep and the requirements relating to documentation of the complaint. Accordingly, we find your response to be inadequate.
- You did not establish and follow written procedures for holding and distributing operations in accordance with 21 CFR 111.453. Specifically, during the inspection you could not produce written procedures for holding and distribution operations.
With your response letter dated August 19, 2011, you provided a copy of SOP QA-003 Holding and Distribution Operations, which you created to resolve the above issue. This SOP does not address holding components and dietary supplements under appropriate conditions of temperature, humidity, and light, as required by 21 CFR 111.455(a). Additionally, this SOP fails to address holding reserve samples of dietary supplements in a manner that protects against contamination and deterioration, as required by 21 CFR 111.465. Accordingly, we find your response to be inadequate.
- You did not establish and follow written procedures for when a returned dietary supplement is received, as required by 21 CFR 111.503. Specifically, during the inspection you could not produce written procedures for handling returned dietary supplements.
With your response letter dated August 19, 2011, you provided a copy of SOP S/R-003 Receiving Returned Products, which you created to address the above issue. Based on our review, this SOP fails to address all of the requirements in 21 CFR 111.535. Specifically, the SOP failed to provide for: written procedures for any material review and disposition decision on a returned dietary supplement; the results of any testing or examination conducted to determine compliance with product specifications; documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed; and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications. Accordingly, we find your response to be inadequate.
- You did not make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR 111.14(b)(2). Specifically, you were unable to provide any documentation to indicate that you have performed training of your personnel. Our investigator was informed by the CEO, that when hired, employees shadow personnel and are also trained by their department managers.
In your response letter dated August 19, 2011, you provided SOP G-002 General Training Records, but did not provide a copy of the “Record of Training” form as identified in the SOP. You also stated in your letter that you would re-train and document all employees who work with labels or product; however, you failed to provide any documentation verifying that this training has been implemented. Consequently, we find your response inadequate and will verify your documentation of training at the next scheduled inspection of your firm.
Unapproved New Drugs
During the inspection at your facility, our investigators collected labels associated with many of your products. Based on our review of your product labeling, we have determined that the products “Borage CP-240, CoQmax CF, Immune Rx, Iron Glycinate, and Green Tea 600” are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your labels establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
The following claims are found on your Desk Reference Sheets (DRS) you provide to customers on request and are available for download through your website at www.xymogen.com. Examples of some of the claims observed on your product labeling include:
Borage CP-240 (As declared on your DRS)
- “Clinical Applications
- Reduce Inflammation (Pain, Stiffness, Joint Tenderness)”
- “Skin disorders, alcoholism, atrophic gastritis, asthma, . . . and periodontal disease are among other conditions for which borage oil may be helpful.”
CoQmax CF (As declared on your DRS)
- “Clinical Applications
- …Low Energy Syndromes, Genetic Disorders and Drugs that interfere with CoQ10 and or Energy Production”
- “Support for Cardiovascular Conditions e.g.: Hypertension, Heart Failure, Angina Pectoris, Arrhythmia, Acute Reperfusion Injuries and Acute Myocardial Infarction”
- “Support for Neuromuscular Disorders and Age Related CNS Degeneration Conditions”
Immune Rx (As declared on your DRS)
- “Clinical Applications
- Cancer Risk Factors
- Cardiovascular Risk Factors”
- “Resveratrol, (a component in your product)…has been widely researched for its anti-inflammatory, anti-oxidative, and anticarcinogenic effects.”
- “Lycopene, (a component in your product)…anticarcinogenic according to research”
- “Green Tea (a component in your product)research has demonstrated a cancer-protective effect on breast, lung, and prostate cancer….”
- “Selenium (a component in your product)…clinical studies have shown that Se can decrease the risk for several types of human cancers, including prostate, lung, breast, and colon cancer.”
- “Rosemary Extract (a component in your product)…exhibit[s]…anticarcinogenic activity in various cell models.”
- “Calcium D-Glucarate (a component in your product)…lowering the risk of chemical carcinogenesis, estrogen-dependent breast cancer, and prostate cancer.”
- “Folate (a component in your product)…modulates the risk of developing cancers in selected tissues including breast and colon.”
Iron Glycinate (As declared on your DRS)
- “Clinical Applications
- Iron Deficiency Anemia…
- Gastritis, Ulcer”
Green Tea 600 (As declared on your DRS)
- “Clinical Application …
- Herpes Simplex Virus Type 1”
- “Green tea's ability to chelate iron may offer neuroprotection in related disease such as Alzheimer’s, Parkinson's etc.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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.
In addition, your “Borage CP-240, CoQmax CF, Immune Rx, Iron Glycinate, and Green Tea 600” products are being offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Therefore,these products are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of the Act and FDA regulations. You should take prompt action to correct the violations cited in this letter and prevent their further recurrence. Failure to promptly correct these violations may result in legal action without further notice, including, but not limited to, seizure and injunction. We will verify the adequacy of your corrections at our next inspection.
In addition, we offer the following comments related to your dietary supplement operation:
- You did not control the issuance and use of labels, as required by 21 CFR 111.410(b). Specifically, your firm is not controlling the issuance and use of your private labels that are printed off computers by your employees. During the investigator’s walk through of your firm, you stated to our investigator that the private label fulfillment room is where the labels are printed out and the labels that are not used are shredded; however, this practice is not documented. In your response letter dated August 19, 2011, you state that you have developed a sign-off for every label print and have conducted and documented a monthly audit for the number of labels used (SOP QC-003). However, you did not provide sufficient information for us to evaluate whether this correction is adequate. We will verify the adequacy of this correction during our next inspection.
- None of the SOPs submitted with your response letter were signed “approved by” your quality control division. Please have your quality control division review and approve these SOPs, as required by 21 CFR 111.105(a).
- You did not hold labels under conditions that do not lead to mix-up, contamination, or deterioration, as required by 21 CFR 111.455(c). Specifically, our investigator observed the storage of your labels in an unlocked room, the manager’s office, and in the private label fulfillment room. These areas are unsecured and uncontrolled and storing labels in this manner can result in mix-ups. In your response letter dated August 19, 2011, you stated that all labels are signed off by quality control in accordance with SOP QA-002 prior to utilization. Additionally, you state that you are now housing your labels in secure label storage areas and have constructed new cabinetry that can be locked. Furthermore, you mentioned that, as part of your corrective action, you are instituting a sign-in and sign-out sheets for labels. However, you did not provide sufficient information for us to evaluate whether this correction is adequate. We will verify the adequacy of this correction during our next inspection.
- You did not make and keep written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.140(b)(1). Specifically, your firm has not established written procedures for quality control operations. During the inspection, you indicated that you have employees who approve and release from quarantine all products received for labeling along with actual labels, review and approve all records for label operations, and various other responsibilities. However, you did not provide any evidence of the written procedures required by 21 CFR 111.140(b)(1). With your response letter dated August 19, 2011, you provided a number of SOPs which establish written procedures for the responsibilities of your quality control operations. However, you did not provide sufficient information for us to evaluate whether this correction is adequate. We will verify the adequacy of this correction during our next inspection.
- At the time of the inspection you did not have a recall procedure in place. We recommend that you implement a recall procedure and conduct “mock” recalls on a regular schedule to ensure that you have the ability to adequately address unforeseen problems that may arise in the future with the products you label, hold, and distribute, including private labeled products.
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 these violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete the corrective actions within fifteen working days, you should state the reason for the delay and state when you will correct any remaining violations.
Address your reply to the U.S. Food and Drug Administration, 555 Winderley Place Suite 200, Maitland Florida 32751, Attention: Carla Norris, Compliance Officer.
Director, Florida District