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
- 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.
- 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).
- 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.
- 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.
- 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.
- “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.”
- “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”
- “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.”
- “Clinical Applications
- Iron Deficiency Anemia…
- Gastritis, Ulcer”
- “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.”
- 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.