Inspections, Compliance, Enforcement, and Criminal Investigations
Ion Labs Inc. 12/5/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Ste 200
1. Your firm failed to verify that your finished batch of dietary supplements met established product specifications for purity and strength, as required by 21 CFR 111.75(c). You must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)), and determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c). Specifically, you provided our investigator with finished assay test data on the products you manufacture, including assay data on product FaBB (batch# 030013 and 030014). However, our review of the assay data revealed that they were insufficient to meet this requirement. Your assay data did not provide quantitative data to determine if the specifications for your finished products were met. Further, the concentration (strength) for the referenced standards was not provided.
We reviewed your response and exhibits 1-4 dated June 23, 2011 and found it to be inadequate. You submitted a standard operating procedure (SOP) entitled “Minimum Finished Product Testing Requirements for Nutritional Product.” However, this SOP appears to only address the identity requirement. It does not address your responsibility to verify the purity, strength, and composition specifications of your finished products. You also submitted finished product specification sheets for the products Kidney Cleanse, Liver Cleanse, Slim System, and Natural Moves. However, these product specification sheets do not list the required specifications under 21 CFR 111.70(e).
2. You failed to establish laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting reference materials used in performing tests and examination, as required by 21 CFR 111.315(d). Specifically, you indicated to our investigators during the inspection that your non-compendia reference standard materials (i.e., spectrum graphs) for the (b)(4) transform infrared spectroscopy ((b)(4)TIR) are selected from previous component shipments received and analyzed by your (b)(4)TIR equipment. However, you failed to establish any criteria (i.e., characterization) to establish a reference standard. Non-compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength.[OGC1]
3. You reprocessed dietary supplements, but failed to have quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approve the reprocessing, as required by 21 CFR 111.90(b)(1). The person who conducts a material review and makes the disposition decision must document that at the time of performance [21 CFR 111.113(b)(2)], and you are required to make and keep these records [21 CFR 111.140(b)(3)]. Specifically, you were unable to produce documentation that quality control personnel conducted a material review, made a disposition decision, and approved the reprocessing of the following:
- Slim System tablets, batch # 020194, failed its tablet specifications (e.g., hardness) due to “flow” issues during tablet compression and the product was reprocessed. You indicated to our investigators that the product was reprocessed by a process called (b)(4)
- Ion Kidney Flush tablets, batch # 12005, failed its tablet specification (e.g., hardness) due to flow issues during tablet compression and the product was reprocessed.
4. Your firm's batch production records do not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. For example, the batch records for Zen Cleanse Liver Cleanser (batch # 020336), Zen Cleanse Kidney Cleanser (batch # 120005), Prostate Men’s Health (batch # 020321), Vita Trum SR (batch #020371), and Vita-TRUM 50 + (batch # 020268) lack the batch production information related to the tablet coating of these products. Your Master Formula for these products indicated that these tablets were coated and that some were outsourced for coating. However, there is no information in your batch records to show the coating process of these tablets.
5. Your firm did not establish specifications for each component that you use in the manufacture of your dietary supplements, including (1) an identity specification; (2) component specifications that are necessary to ensure that specifications that are necessary to ensure that the specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and (3) limits on those types of contamination that may adulterate or may lead to adulteration on the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required in 21 CFR 111.70(b). For example, your firm failed to establish identity, purity, strength, and composition specifications for the Vitamin A Acetate 500,000 IU (ION Labs Raw Material Test Ticket date received 1/17/11) and Choline Bitartrate (ION Labs Raw Material Test Ticket date received 9/9/10) used in the manufacture of your dietary supplements. These Test Tickets list some tests and specifications, but the specifications listed did not meet the requirements under 21 CFR 111.70(b) for the purity and composition specifications of the components, and, as applicable, limits on the types of contamination that may adulterate or may lead to adulteration of the finished products.
- Zen Cleanse Liver Cleanse, batch # 020336 deviated from the MMR in that Choline Bitartrate 1% powder was replaced with Choline Bitartrate 41% powder.
- Natural Moves, batch # 020331 deviated from the MMR in that calcium carbonate was added to the batch, but not part of the MMR. Also, additional amounts of microcrystalline cellulose were added beyond the amount listed in the MMR.
- Wintergreen ContentMints, batch # 020305 deviated from the MMR in that additional amount of 1% of Magnesium Stearate Powder was added to the batch.
7. When a dietary supplement does not meet a specification established in accordance with 21 CFR 111.70(a), quality control personnel must reject the dietary supplement, unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in 21 CFR 111.77 [21 CFR 111.77(a) and 111.113(b)(2)]. However, your firm's quality control personnel approved the release of the following finished batches of product that did not meet specifications established under 111.70(a):
- Native Remedies Natural Moves, batch # 020331, when finished product specification failed for tablet hardness, as referenced in your ION Labs Test Ticket (Compression Startup Check) dated 1/5/11.
- Calming Essence ContentMints, batch # 020305, when finished product specification failed for tablet hardness, as referenced in your ION Labs Test Ticket (Compression Startup Check) dated 12/14/10.
- Ribbon Nutrition Pure IGP, batch # 020311, when finished product specification for tablet hardness, as referenced in your ION Labs Test Ticket (Compression Startup Check) dated 12/1/10.
8. Your firm's Master Formula (Master Manufacturing Records (MMR)) for the Vitra TrumSR, Vita-TRUM 50+ Multi, Prematria Prenatal, Kidney Flush, Ion Liver Flush, and Prostate Health products did not include the following information required by 21 CFR 111.210:
- A statement of the expected yield of the manufactured 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 decision is made. [21 CFR 111.210(f)].
- A description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
- Written instructions, including: