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U.S. Department of Health and Human Services

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Enforcement Actions

Atrium Inc. 11/2/12

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

 
November 2, 2012
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUSTED                                      
Refer to MIN 13 – 06
 
 
James F. Sommers
Owner and President
Atrium, Inc.
440 S. Townline Road
Wautoma, Wisconsin 54982-6922
 
Dear Mr. Sommers:
 
On January 10-11, 18 and 24, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing plant located at 440 S. Townline Road, Wautoma, Wisconsin. During the inspection we evaluated the manufacturing of the ASPEN CHOLE-STERIN, Eversco Kalmz, chole-sterin supreme Red Yeast Rice, adreno medulla plus, and chole-sterin supreme Phyto Sterol Red Yeast Rice products manufactured at your facility.  Because you label these products as dietary supplements, we evaluated whether the products were prepared, packed, and held under conditions that comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21, Code of Federal Regulations (21 CFR) Part 111. However, this letter should not be interpreted to mean that FDA agrees with your characterization of the products or their ingredients. 
 
During the inspection, our investigator found a number of violations of the dietary supplement CGMP regulations. These violations cause the products manufactured at your facility 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 the CGMP regulations for dietary supplements.
 
In addition, our review of your atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, pineal plus, atri-acidic, hypothalamus 50, and Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50 and Nutripak GLAND FEM products revealed that these products are adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), of the Act. These products are adulterated within the meaning of section 402(a)(4) because they are manufactured from, processed with, or otherwise contain material from cattle, but you have failed to establish and maintain records sufficient to demonstrate that they are not manufactured from, processed with, or do not otherwise contain prohibited cattle materials.
 
Furthermore, during our inspection, FDA also collected samples and labeling for several of your products, and we conducted a review of your websites www.atriuminc.com, www.nutripakonline.com, and www.aspennutrients.com in July 2012. Based on our review of your labeling and websites, we have determined that several of your products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your labeling establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  The marketing of your products with these claims violates the Act. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov
 
We also note that we received your letter dated February 14, 2012, responding to the form FDA-483 Inspectional Observations (FDA-483) that we issued on January 24, 2012. We address your response below.
 
Dietary Supplement CGMP Violations
 
1.    You failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70. Specifically:
 
  • You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Our investigator observed that you have no such specifications.
  • You failed to establish product specifications for the identity, purity, strength, and composition for each dietary supplement product you manufacture, as required by 21 CFR 111.70(e). For example, you did not provide any finished product specifications for the following products: 
o   ASPEN CHOLE-STERIN, lot 0613
o   chole-sterin supreme Phyto Sterol Red Yeast Rice - Yellow Label, lot 0964
o   chole-sterin supreme Red Yeast Rice - White Label, lot 0965
o   adreno medulla plus, lot 1566
 
In addition, we note that manufacturers are responsible for more than establishing specifications. Once you have established the specifications under 21 CFR 111.70, you must determine whether the specifications have been met, as required by 21 CFR 111.73.
 
Although your February 14, 2012, response to the FDA-483 addresses these violations, your response is inadequate. You state that you will address your failure to establish product specifications for each dietary supplement product you manufacture by instituting (b)(4) method for determining final product specifications by using (b)(4).   However, you must prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement, and for each batch size, to ensure uniformity in the finished batch, from batch to batch; the MMR must establish controls and procedures to ensure that each batch of dietary supplement meets specifications to ensure that the finished dietary supplement consistently meets the established specifications for identity, purity, strength, and composition (see 21 CFR 111.205). Your proposed solution, however, will not ensure that you meet established specifications in the MMR to ensure the quality of the dietary supplement from batch to batch. You are describing a situation where you are changing your specifications based on (b)(4). As to your failure to establish specifications for each component, you state that you purchased a (b)(4) “with 21 CFR Part 111 technically compliant software suite.” The (b)(4) spectrometer is acceptable for determining the identity of a component; however, the various tests you propose will not determine what specification initially needs to be established for the component. 
 
2.    You failed to prepare a written MMR for each batch size of a dietary supplement that you manufacture, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically:
 
  • For batch record #1566 of adreno medulla plus, the MMR was for a (b)(4) tablet batch, but the operators made a (b)(4) tablet batch. No MMR exists for a (b)(4) tablet batch.
  • For batch #1279 of Eversco Kalmz, the MMR was for a (b)(4) capsule batch. The semi-auto capsule filling machine log shows batch #1279 made (b)(4) capsules on 9/8/11. When asked by our investigator how this was possible, we were told that your firm actually manufactured a batch larger than (b)(4) to fill a larger order.  However, no MMR exists for a larger batch size. 
 
Additionally, your MMRs for your adreno medulla plus, Eversco Kalmz, chole-sterin supreme Phyto Sterol Red Yeast Rice and chole-sterin supreme Red Yeast Rice failed to contain the following required information, as specified in 21 CFR 111.210. Specifically:
 
  • You must include a description of the packaging and a representative label, or a cross-reference to the physical location of the actual or representative label, 21 CFR 111.210(g). However, your MMRs failed to include this information.
  • You must include written instructions for specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, 21 CFR 111.210(h)(1). However, your MMRs failed to include this information.
  • You must include written instructions for procedures for sampling and a cross-reference to procedures for tests or examinations, 21 CFR 111.210(h)(2). However, your MMRs failed to include this information.
  • You must include written instructions for specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, 21 CFR 111.210(h)(3).  However, your MMRs failed to include this information.
  • You must include written instructions for corrective action plans for use when a specification is not met, 21 CFR 111.210(h)(5).  However, your MMRs failed to include this information.
 
We acknowledge that your February 14, 2012, response to the FDA 483 addresses this violation, stating that MMRs are being written. This response is incomplete. You have not provided copies of your revised MMRs or a timeline for the completion of this corrective action. Without such documentation, we cannot verify whether you have, in fact, taken corrective action.
 
3.    Your batch production records (BPRs) for your adreno medulla plus, Eversco Kalmz, chole-sterin supreme Phyto Sterol Red Yeast Rice and chole-sterin supreme Red Yeast Rice products failed to include required information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically:
 
  • You must include the identity of equipment and processing lines used in producing the batch, 21 CFR 111.260(b). However, your BPRs failed to include this information.
  • You must include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines, or a cross-reference to records, such as individual equipment logs, where this information is retained, 21 CFR 111.260(c).  However, your BPRs failed to include this information.
  • You must include the unique identifier that you assigned to each component. The lot number of capsules used is not recorded, 21 CFR 111.260(d). However, your BPRs failed to include this information.
  • You must include a statement of the actual yield, 21 CFR 111.260(f). However, your BPRs failed to include this information.
  • You must include the actual results obtained during any monitoring operation, 21 CFR 111.260(g). For example, tablet press and encapsulator operators reported they perform weight checks every (b)(4) minutes during a production run. Results of this monitoring are not documented. 
  • You must include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for adding a component to the batch, 21 CFR 111.260(j)(2)(iii). However, your BPRs failed to include this information.
  • You must include documentation, at the time of performance, of packaging and labeling operations, including the unique identifier that you assigned to packaging used and the quantity of the labels used, 21 CFR 111.260(k)(1). However, your BPRs failed to include this information.
  • You must include documentation, at the time of performance, of an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR, 21 CFR 111.260(k)(2). However, your BPRs failed to include this information.
  • You must include documentation, at the time of performance, that quality control personnel reviewed the batch production record, 21 CFR 111.260(l)(1). However, your BPRs failed to include this information.
 
Although your February 14, 2012, response to the FDA-483 addressed this violation, your response is inadequate. You have not provided our office any copies of your revised BPRs or a timeline for the completion of this corrective action. By not including a means for us to verify the status of your corrective action plan, we cannot determine if it is being implemented. 
 
4.    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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you have no written procedures for quality control operations.  
 
We acknowledge that your February 14, 2012, response to the FDA-483 addresses this violation, but we find it to be inadequate. You state in your response that “standard operating procedures [SOPs] will be written or modified for various QC operations” and “QC will be implemented in critical points throughout the manufacturing process including raw material incoming, formulation chart, weighing mixing records, compression or filling records, labeling and packing and final product release.” However, your proposed SOPs do not fulfill the requirements in Subpart F of the dietary supplement CGMP regulations. For instance, the SOPs do not include procedures for the visual examinations required in 21 CFR 111.155(a)-(b), or for quarantining of components, as required in 21 CFR 111.155(c).
 
5.    You failed to examine, before labeling operations, your labels for each batch of dietary supplement to determine whether the labels conform to the MMR, as required by 21 CFR 111.410(c). Our investigator determined that you failed to conduct such examinations because several MMRs call for the use of rice powder, but the finished product labels failed to declare rice powder as an ingredient.
 
  • ASPEN CHOLE-STERIN, lot 0613
  • chole-sterin supreme Phyto Sterol Red Yeast Rice - Yellow Label, lot 0964
  • chole-sterin supreme Red Yeast Rice - White Label, lot 0965
 
Although your February 14, 2012, response to the FDA-483 addresses this violation, providing that you are in the process of replacing all labels, this response is incomplete. You have not provided our office with copies of your revised or proposed labels declaring rice powder as an ingredient.  We are therefore unable to verify whether you have taken the necessary corrective action. We will verify the steps you have outlined in your action plan at our next scheduled inspection. 
 
6.    You failed to establish written procedures, as required by 21 CFR 111.553, to fulfill the requirements of 21 CFR 111.560 concerning the review and investigation of product complaints. Specifically, your firm verbally confirmed to our investigator that you do not have written procedures to address product complaints.
 
Your February 14, 2012, response to the FDA-483 addresses this violation but is not adequate. Your response states the following:  “Upon receiving a customer complain[t] concerning a product, a faxable form is sent to the customer to be filled out or it can be filled out over the phone.  Once the product of concern has been identified, a sample of the product is sent to Master Formulator (b)(6) and a call tag is placed on the product.  (b)(6) diagnoses the problem and makes a disposition.  In all cases, a new product is then sent to the customer from a different lot of the same product.” This response fails to address the procedures you will take to investigate product complaints. 
 
Recordkeeping Requirements for Human Food Containing Material from Cattle
 
In addition, FDA reviewed the ingredients used in the following products you manufacture:  atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, hypothalamus 50, pineal plus, atri-acidic, Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50, and Nutripak GLAND FEM. Based on the labeling for these products and information our investigator learned during the inspection, FDA has determined that these products are manufactured from, processed with, or otherwise contain material from cattle. Specifically:
 
  • Your atri-zinc chelate plus product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
  • Your atri k-chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
  • Your atri cu-chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
  • Your atri-cal chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
  • Your atri mag chelate plus product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
  • Your aller-cal product contains “Raw Pituitary Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” and “Raw Parathyroid Concentrate (Bovine);”
  • Your glan-male plus product contains “Raw Adrenal Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
  • Your glyco-b product contains “Raw Brain Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” “Raw Liver Concentrate (Bovine),” and “Raw Pancreas Concentrate (Bovine);”
  • Your hypothalamus 50 product contains “Raw Hypothalamus Concentrate (Bovine);”
  • Your pineal plus product contains “Raw Whole Pituitary Concentrate (Bovine)” and “Raw Pineal Tissue Concentrate (Bovine);”
  • Your atri-acidic product contains “Raw Duodenum Concentrate (Bovine);”
  • Your Nutripak HYPOTHALAMUS 50 product contains “Raw Hypothalamus Concentrate (Bovine);”
  • Your Nutripak CALCIUM CHELATE product contains “Raw spleen concentrate (Bovine),” “Raw brain concentrate (Bovine),” “Raw liver concentrate (Bovine),” “Raw heart concentrate (Bovine),” “Raw Kidney Concentrate (Bovine),” “Raw Pancreas Concentrate (Bovine),” “Raw Duodenum Concentrate (Bovine),” “Raw Thymus Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” and “Raw Pituitary Concentrate (Bovine);”
  • Your Nutripak GLAND FEM product contains “Raw Adrenal Concentrate (Bovine),” “Raw Pituitary Concentrate (Bovine),” and “Raw Ovary Concentrate (Bovine).”
 
Under 21 CFR 189.5(d)(1), these products that you manufacture are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that you have failed to establish and maintain records sufficient to demonstrate that they are not manufactured from, processed with, or do not otherwise contain prohibited cattle materials, as required by 21 CFR 189.5(c).  Prohibited cattle material includes specified risk materials, small intestine of all cattle (unless the distal ileum portion of the small intestine has been removed as specified in FDA regulations), material from non-ambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (beef). See 21 CFR 189.5(a)(1).[1] The recordkeeping requirement in 21 CFR 189.5(c) applies to human food, including dietary supplements. 
 
Furthermore, we note that under the dietary supplement CGMP regulations, for both cattle-derived and other animal-derived materials, you must comply with 21 CFR 111.70, which requires dietary supplement manufacturers to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.  Thus, you must establish specifications for animal-derived materials that are necessary to ensure the quality of the dietary supplement. See 72 Federal Register 34752, 34839. 
 
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 labels and review of your websites www.atriuminc.com, www.nutripakonline.com and www.aspennutrients.com, in July 2012, we have determined that the products ASPEN CHOLE-STERIN, resveratrol supreme, atri-probiotic supreme, Parasit-X, Glucobetic and ASPEN CALCIUM with Red Yeast Rice 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 dietary supplement products with these claims violates the Act. 
 
Examples of some of the claims observed on your product labeling include: 
ASPEN CHOLE-STERIN (60 capsules):
 
  • “MAY LOWER LDL CHOLESTEROL”
  •  “MAY IMPROVE HDL/LDL RATIO”
  • “NATURAL CHOLESTEROL BLOCKER”
 
resveratrol supreme (100 Capsules)
  • “[T]hat also can help with cholesterol and anti-cancer.”
 
atri-probiotic supreme (60 Capsules)
  • “Use as aid…under conditions of digestive disorders & following antibiotic therapy”
 
Parasit-X (90 Capsules)
  • “Each capsule contains a botanical formaul [sic] to help with cleansing of parasites.”
  • “For routine semi-annual parasite prevention….”
 
Glucobetic (90 Capsules)
  • “[T]o normalize elevated blodd [sic] sugar levels.”
 
In addition, the label for your product Aspen CALCIUM with Red Yeast Rice states that “RED YEAST RICE has 0.4% Lovastatin.” Lovastatin is the active pharmaceutical ingredient in (b)(4) and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Since Lovastatin’s approval as a new drug preceded its marketing as a food or dietary supplement, your Aspen CALCIUM with Red Yeast Rice product is disqualified from the dietary supplement definition. 
 
Consequently, 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. 
 
The above violations are not intended to be an all-inclusive list of violations at your facility or deficiencies in your products or their labeling.  It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. You should take prompt action to correct the above violations. If you do not promptly correct them, you may be subject to regulatory action without further notice, such as seizure and/or injunction.   
 
Please be advised a description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
 
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
 
You should notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time within which the corrections will be completed. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
 
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address on the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114. 
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District


[1] Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle.