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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Basic Organics, Inc.12/7/12

  

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

Public Health Service
Food and Drug Administration
 Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237

Via United Parcel Service

December 7, 2012

Scott A. Johnson, Owner
Basic Organics, Inc.
885 Claycraft Rd.
Columbus, OH 43230-6651

WARNING LETTER CIN-DO 13-296697

Dear Mr. Johnson:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 885 Claycraft Rd., Columbus, OH, on March 26 - April 6, 2012. During the inspection, you stated that your firm is a dietary supplement distributor that contracts with manufacturers to manufacture your dietary supplement products under your firm's name. Your firm packages, labels, holds, and distributes dietary supplement products. You stated during the inspection that you are exempt from the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111) because your dietary supplements are contract manufactured for you. To the extent that you contract with another manufacturer to manufacture dietary supplements for you, that your firm packages and labels and then releases for distribution under your firm's name, you are ultimately responsible for complying with the requirements related to manufacturing operations, even though you have hired another person to perform that job task [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Moreover, there are dietary supplement CGMP requirements related to your packaging, labeling, holding, and distributing operations.

The inspection revealed serious violations of the CGMP regulations for dietary supplements. These violations cause your Glucosamine Chondroitin and Omega 3 dietary supplements 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. You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.

The significant violations related to your packaging, labeling, holding, and distributing operations are as follows:

1. You failed to identify quality control personnel, as required by 21 CFR 111.12(b), and 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, your Operations Manager failed to identify any employee(s) to be responsible for your quality control operations, and stated that there are currently no quality control operations happening at your firm. In addition, you provided no written procedures required by 21 CFR 111.103.

We received your written response to the FDA-483 dated April 24, 2012, which indicates that you will correct these violations with your Standard Operating Procedure and an organization list. Your Standard Operating Procedure for Vend or Qualification appears to identify quality control personnel, as required by 21 CFR 111.12(b). We will verify the adequacy of your correction at our next inspection.

However, your response is inadequate because you failed to outline the specific steps you will take to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103 and you did not provide supporting documentation for FDA to evaluate the adequacy of your proposed corrective actions. For example, your Standard Operating Procedure for Vendor Qualification appears to address quality control personnel's responsibility to review and approve the documentation setting forth the basis for qualification of any supplier, as required by 21 CFR 111.105, but it does not address quality control personnel's responsibility to determine whether all specifications established under 21 CFR 111.70(a) are met, as required by 21 CFR 111.105(h).

2. You failed to prepare and follow a written master manufacturing record (MMR) to ensure that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.205(b)(1). Specifically, your firm bottles, labels, seals, and distributes dietary supplements, but you do not have a MMR for your dietary supplement products that includes specifications applicable to packaging and labeling.

Your written response, dated April 24, 2012, is not adequate. Your response states that a copy of the MMR was enclosed. However, the document enclosed in your response appears to be a Standard Operating Procedure, not an MMR. An MMR is a step-by-step description of the manufacturing operations, including packaging and labeling operations, that identifies specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, and establishes controls and procedures to ensure that each batch of dietary supplement that is manufactured meets such specifications, as required by 21 CFR 111.205(b). You need to create an MMR for your packaging and labeling operations for each unique formulation of dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205. An MMR for a firm that only packages and labels the dietary supplement must include specifications that are applicable to its operations [See 72 Fed. Reg. 34752, 34902 (June 25, 2007)].

3. You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.70(a). Specifically, you failed to establish packaging and labeling specifications for each dietary supplement, as required by 21 CFR 111.70(d), and determine whether these specifications established under 21 CFR 111.70(d) are met, as required by 21 CFR 111.73. Our investigator found during the inspection that there are no documented specifications for the packaging and labeling used for your dietary supplement products.

Your written response, dated April 24, 2012, states that this violation will be corrected with implementation of an MMR. However, your response is inadequate because you did not provide an MMR for our review and did not otherwise provide supporting documentation of packaging and labeling specifications that you established for your dietary supplement products.

4. You failed to establish and follow written procedures for when a returned dietary suplement is received to fulfill the requirements of 21 CFR Part 111, Subpart N, as required by 21 CFR 111.503. Specifically, there is no written procedure to be followed when any product is returned, and the disposition decision of the product is not documented.

Your written response dated April 24, 2012, states this violation will be corrected with a Standard Operating Procedure for returns. However, a copy of your Standard Operating Procedure for returns was not included with your response. Thus, we are unable to determine the adequacy of your proposed corrective action.

5. You failed to establish and follow written procedures for product complaints to meet the requirements of 21 CFR Part 111, Subpart 0, as required by 21 CFR 111.553. Specifically, you did not provide documentation of written procedures for product complaints, as required by 21 CFR 111.553.

6. 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, your Operations Manager failed to provide reserve samples of any of the dietary supplements that you distribute.

Your written response dated April 24, 2012, states this violation will be corrected with your Standard Operating Procedure for Operation of Bulk to Bottle, which directs operators to hold of all new lot numbers for one year past the expiration date for dietary supplements that you bottle. We will verify the adequacy of your proposed corrective action during our next inspection. Please note that you must collect and hold reserve samples of not only dietary supplements that you bottle, but also each lot of dietary supplement that you distribute. Reserve samples must be collected and held in accordance with 21 CFR 111.83(b).

7. Your batch production records (BPRs) failed to include complete information relating to the production of and control of each batch of dietary supplement that you package and label, as required by 21 CFR 111.255(b). Specifically, your firm fills out a "Basic Organics Bulk to Bottle Product" sheet when bottling your dietary supplement products. However, this BPR for your dietary supplements did not include the following required information:

• Date and time of maintenance, cleaning, and sanitizing of equipment used to package and label the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];

• 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)];

• Results of any tests or examinations conducted on packaged and labeled dietary supplements, or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)];

• Documentation at the time of performance that quality control personnel reviewed the batch production record [21 CFR 111.260(1)(1)];

• Documentation at the time of performance that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement [21 CFR 111.260(1)(4)]; and

• Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]

Your written response dated April 24, 2012, states this violation will be corrected with a Standard Operating Procedure for bottling bulk product. However, you did not provide a copy of a BPR, or your "Basic Organics Bulk to Bottle Product" sheet, with the information required by 21 CFR 111.260. Please note that a BPR for a firm that only packages and labels a dietary supplement product only needs to include those parts of a BPR relevant to the packaging and labeling processes [See 72 Fed. Reg. 34752, 34886 (June 25, 2007)].

8. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you did not provide documentation of written procedures for holding and distributing operations, as required by 21 CFR 111.453.

Your written response dated April 24, 2012, states this violation will be corrected with a Standard Operating Procedure for receiving and labeling. However, a copy of your Standard Operating Procedure was not provided in order for FDA to determine if it will be adequate to ensure that your products are held and distributed in accordance with 21 CFR Part 111, Subpart M.

The above violations are not meant to be an all-inclusive list of the violations at your facility or that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and applicable FDA regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement actions without further notice, such as seizure and/or injunction.

In addition to the violations discussed above, we have the following comments:

1. To the extent that you are receiving products from a supplier, you must establish specifications to provide sufficient assurance that the product you receive from a supplier for packaging, labeling, and distributing as a dietary supplement is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). In addition, you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).

2. To the extent that another firm is manufacturing dietary supplements at your direction, you are ultimately responsible for the manufacturing operations even though you have hired another person to perform those job tasks [72 Fed. Reg. 34752 at 34790; June 25, 2007]. Your firm has an obligation to know what and how manufacturing activities are performed, so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. Under such circumstances, you are required to have records related to manufacturing operations (e.g., specifications, master manufacturing records) readily available during the retention period for inspection and copying by FDA when requested (21 CFR 111.610).

3. You must establish and follow written procedures for personnel, to fulfill the requirements of 21 CFR Part 111, Subpart B, as required by 21 CFR 111.8, including the prevention of microbial contamination from sick or infected personnel and for hygienic practices, as required by 21 CFR 111.10.

Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your reply should include the specific steps that you have taken to correct the violations cited above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Your response should be sent to U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, Attention: Karen Gale Sego, Compliance officer. If you have questions regarding the content of this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164.

Sincerely,

/S/

Paul J. Teitell
District Director
Cincinnati District

 

redacted cc: Charles Kirchner, Chief, Food Safety Division
                  Ohio Department of Agriculture
                  8995 East Main Street
                  Reynoldsburg, OH 43068-3399