Inspections, Compliance, Enforcement, and Criminal Investigations
Global Source Management & Consulting 9/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
- “The Best Arthritis Formula***ENJOY LIFE AGAIN WITHOUT PAINFUL JOINTS***Experience Profound Relief And Fluidity Of Motion***”
- “[R]etards the growth of new blood vessels that cause inflammation.”
- “[T]o rebuild healthy cartilage.”
- “It has powerful anti-inflammatory properties while also providing protection against irritation for the stomach lining ...”
- “[L]iterally melt arthritis pain away. It takes up to sixty days for sea cucumber to create and then maintain proper inflammatory response”
- “[H]as demonstrated effectiveness against cancer cells in the test tube....”
- “This African herb fights both pain and inflammation of the joints and also lowers uric acid.”
- “Helps many areas … specifically for Arthritis it helps relieve inflammation….”
- “[S]hown to . . . increase sensitivity to insulin … helps protect against mercury and poison mushroom toxicity … helps protect inner ear from drug toxicity”
- “Diabetic Support”
- “With a staggering percentage of the male population suffering from some form of prostate related ailment…. [P]rostate Support … works collaboratively to offer an unparalleled level of prostate protection.”
- “May be beneficial for … psoriasis”
- “Natural Herbal Diuretic”
- “Many herbs can be beneficial if you are suffering from edema….”
- “Juniper berries and Uva ursi are both potent diuretics that increase the output of urine, and help correct edema.”
- “Parsley also has diuretic properties….”
- “May be beneficial for psoriasis”
- “May slow Alzheimer’s progression … May aid a variety of disorders that are circulation related including tinnitus (ringing in the ears), and impotence.”
- “Good for anemia, chronic fatigue syndrome, impotence.…”
- “Peru’s Natural Viagra”
- “[R]ecognized as a healthy anti-inflammatory.…”
- “Studies have also shown this traditionally used kidney disease herb ... also improved quality of life in patients with Chronic Renal Failure.”
- “[R]educes mucus from colds. Good for … high blood pressure, insomnia, irritable bowel syndrome … pain … and ulcers”
- You failed to package and label dietary supplements in a way that ensures the quality of the supplements and that the supplements are packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.415. Specifically, during the inspection you verbally confirmed that your firm does not have a MMR for any of the dietary supplement products packaged and labeled by your firm.
- You failed to establish specifications for packaging and labeling dietary supplements to provide sufficient assurance that the product you receive is adequately identified and consistent with your purchase order, as required by 21 CFR 111.70(f). You also failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label. Specifically, during the inspection, you informed our investigator that you did not have any specifications for labeling and packaging dietary supplements. We note that once you have established such specifications, as required by 21 CFR 111.70(f) and (g), you must also determine whether the specifications have been met, as required by 21 CFR 111.73.
- You 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, during the inspection, you informed our investigator that your firm did not have any written procedures for quality control operations.
- Your batch production record failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. During the inspection, you provided our investigator a copy of a “Packing Order” for Glucosamine Sulfate Chondroitin Sulfate with MSM Boron EPO, Lot# 385804, which you said was a representative batch record for each batch of dietary supplement packaged at your firm. However, this batch record did not contain the following required elements:
- The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
- The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines [21 CFR 111.260(c)].
- The unique identifier that you assigned to packaging used and the quantity of the labels issued and used [21 CFR 111.260(k)(1)].
- The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)].
- You failed to establish written procedures to fulfill the requirements of 21 CFR 111.560 relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, during the inspection you verbally confirmed to our investigator that there is no formal system in place to address product complaints. Your process at the time of our inspection included a quarantine area where all products with a complaint are kept, however you do not keep a written log of these formal complaints.
- You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, at the time of inspection you stated to our investigator that your firm does not maintain reserve samples of finished products that are packaged by your firm.
- Your Garlic 500 mg with Parsley, Glucosamine Sulfate Chondroitin Sulfate Complex (90 Softgels), Healthy Essential Oil and Prosta-Aid Double Strength (300 Softgels) are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labels contain false and misleading information regarding the presence of soy in the products. All of the products contain soy in their list of ingredients (i.e., soybean oil), but your labels also declare statements asserting that the products do not contain soy (i.e., “Contains … no soy”). If these products contain soy, statements made in the labeling for these products asserting that such products do not contain soy would be false or misleading. If these products do not contain soy, statements made in the labeling for these products asserting that such products contain soy would also be false or misleading.
- Your Alpha Lipoic Acid 600 mg (60 VCaps), Echinacea Root, Evening Primrose Oil (500 mg, 1000 mg), Ginkgo Biloba Standardized Extract 60 mg (60 Softgels, 300 Softgels), Glucosamine Sulfate Chondroitin Sulfate Complex (90 Softgels), Enteric Coated Max Omega-3 (60 Softgels), Omega-3 with Vitamin D3 (100 Softgels, 300 Softgels), Super Horny Goat Weed, Valerian Root, and C Vitamin (Ascorbic Acid) products are misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the label fails to identify the product using the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)).
- Your products Prosta-Aid Double Strength (60 Softgels, 300 Softgels), Super Horny Goat Weed, and Diabetic Support are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the labels fail to identify the part of the plant (e.g., root, leaves) from which the botanical dietary ingredients in the product are derived, as required by 21 CFR 101.4(h)(1). For example, your Prosta-Aid Double Strength lists Saw Palmetto and Diabetic Support lists Gymnema sylvestre, but they do not identify the part of the plants used.
- Your C Vitamin (Ascorbic Acid), Cod Liver Oil, Colon Super Cleanse (300 Capsules), Echinacea Root, Evening Primrose Oil 500 mg, Evening Primrose Oil 1000 mg, Flax Seed Oil, Lecithin, and Shark Cartilage products are misbranded under section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to include a complete domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The addresses provided are not complete with a street name and/or number.
- During the inspection, we noticed that you did not use adequate screening or other protection against pests, where necessary as required by 21 CFR 111.20(h). Specifically, our investigator observed visible gaps of approximately one inch in width on the right, top, and left sides of the rolling door at the south end of your facility. In addition, our investigator observed wood in poor repair on the lower right side of the rolling door on the south wall of the facility. Further, a live lizard approximately two feet from the packaging and labeling table was observed at the time of inspection. It was noted that an individual from the building management came between our visits and caulked up the door. While caulk may close up the opening in the interim, we recommend that your firm prepare and implement a sufficient corrective action that will be long-term.
- Your ceilings were not designed and constructed so that they can be adequately cleaned and kept clean and in good repair as required by 21 CFR 111.20(d)(1)(i). In particular, on 1/26/2012, our investigator observed damage from water on a ceiling tile over your raw ingredients storage area and in the restroom. In addition, on 2/22/2012, our investigator observed a collapsed ceiling tile from the roof lying on the restroom floor, providing a large opening in the ceiling. Water was dripping from this opening in the ceiling into a bucket at the time of inspection. Moreover, you stated to our investigator that the leaking roof has been an issue with the building management for approximately six months and though the ceiling tiles were replaced; the source of the leak coming from the roof has not been repaired.