Inspections, Compliance, Enforcement, and Criminal Investigations
Consolidated Marketing Unlimited, Inc. 1/10/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
- Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). For example, you did not conduct a test or examination of the dietary ingredients used in the following dietary supplements:
- Cantron® New Millennium Liquid Version (Lot #3211204) using dietary ingredients, Inositol (Lot #TR11177), Potassium Hydroxide (Lot #ZD0453), Sodium Sulfite (Lots #10392 and #92892), Pyrocatechol (Lot #001D8-C), and Cupric Sulfate (Lot #XN3024)
- Hydrazine Sulfate (Lot #HS3011244) using dietary ingredients, Hydrazine Sulfate (Lot #C040216) and Microcrystalline Cellulose (Lot #ZA0565)
- You did not prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your master manufacturing record uses a blank form titled “Manufacturing and Production order” for the encapsulation and bottling of your Cantron® Advanced Scientific Capsule Version (ASV), Mild Silver Protein (MSP) and GH-3 products. This generic batch record form is used as needed and is filled out based on the previous batch record.
- You did not establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). For example, at the time of our inspection your Production Manager stated that the temperature thermometers and weight scales used in the manufacturing of Cantron Liquid lot #3210160 and lot #3211204 were not calibrated and that he did not know how to calibrate them. Also, the pH buffers used for calibrating the equipment had expired on March 2010 and July 2010. In addition, your Food Certified Manager who oversees daily operations told our investigator that they had not established written procedures for equipment controls such as calibration.
- You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of your dietary supplements to ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, your firm lacks written procedures that cover your manufacturing, packaging and labeling, and holding operations.
- You failed to establish a specification for any point, step, or stage 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 master manufacturing record [21 CFR 111.70]. You failed to establish specifications as follows:
- You did not establish specification for any point, step, or stage 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 master manufacturing record [21 CFR 111.70(a)].
- You did not establish specifications for each component that you use in the manufacture of a dietary supplement to include a specification for identity of each component; specifications for purity, strength and composition of dietary supplements manufactured using the components are met; and establishing limits on those types of contamination that may lead to adulteration of the finished batch [21 CFR 111.70(b)].
- You did not establish specifications for in-process production of your raw material blends [21 CFR 111.70(c)].
- You did not establish labeling and packaging specifications for your dietary supplement [21 CFR 111.70(d)].
- You did not establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement [21 CFR 111.70(e)].
- You did not establish specifications for product received from your contract manufacturer to be packaged and labeled for distribution [21 CFR 111.70(f)].
- You did not establish packaging and labeling specifications to ensure that you use the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
- You did not establish and follow written procedures for fulfilling the requirements relating to the packaging and labels you receive, as required by 21 CFR 111.153. Specifically, you stated that you did not have any written procedures to meet the requirements (set forth in 21 CFR 111.160) that apply to the packaging and labels you received and used in the packaging and labeling of your Cantron® (New Millennium Liquid Version and Advanced Scientific Capsule Version), GH-3, Mild Silver Protein and Hydrazine Sulfate products. Furthermore, you did not have documentation that those requirements had been met [21 CFR 111.180(b)(3)].
- You failed to establish 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. You do not have written procedures for the responsibilities of your quality control operations pertaining to the following areas:
- Representative samples and reserve samples [21 CFR 111.105(f) and (g)]
- Laboratory operations [21 CFR 111.110]
- Material review and disposition [21 CFR 111.113]
- Equipment, instruments and controls [21 CFR 111.117]
- Components, packaging and labeling [21 CFR 111.120]
- Master manufacturing batch production records and manufacturing operations [21 CFR 111.123]
- Release of packaged and labeled dietary supplements [21 CFR 111.123(a)(8)]
- Reprocessing [21 CFR 111.130]
- Returned dietary supplements [21 CFR 111.130]
- Your quality control personnel failed to conduct a material review and make a disposition decision when a batch deviates from the master manufacturing record (MMR), including when any step established in the master manufacturing record is not completed and including deviations from specifications, as required by 21 CFR 111.113(a)(2). You are required to make and keep documentation of any material review and disposition decision and follow-up [21 CFR 111.140(b)(3)]. Such documentation must meet the requirements of 21 CFR 111.140(b)(3), including an identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)]; a description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)]; an evaluation of whether or not the deviation or unexpected occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 11.140(b)(3)(iii)]; the identification of the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence [21 CFR 111.140(b)(3)(iv)]; an explanation of what you did with the component, dietary supplement, packaging, or label [21 CFR 111.140(b)(3)(v)]; and a scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].
- 4/23/12 Cantron capsules batch record lot #ASV12103EGEL-B180
- 4/23/12 Cantron capsules batch record lot #ASV12107EGEL-B180
- 4/23/12 Cantron capsules batch record lot #ASV12109EGEL-B180
- 4/23/12 Cantron liquid batch record lot #3210160
- 4/23/12 Cantron liquid batch record (lot # or date not recorded) with Stage I: step 8 occurring at (b)(4)
- 4/23/12 Cantron liquid batch record (lot # or date not recorded) with Stage I: Step 8 occurring at (b)(4)
- Your batch production records failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). The batch records that you provided to our investigators at the time of inspection did not include complete information related to production and in process controls used during production. Specifically, the Manufacturing and Production order used by your firm to document the production of your Mild Silver Protein (MSP) (Lots #12074B and #12068) dietary supplements batches were missing the following information:
- the identity of equipment used during batch production [21 CFR 111.260(b)]
- the date and time of maintenance, cleaning and sanitizing of the equipment used during production of the batch [21 CFR 111.260(c)]
- the actual results obtained during any monitoring operation [21 CFR 111.260(g)]
- the results of any testing or examination performed during the batch production [21 CFR 111.260(h)]
- documentation that the finished dietary supplement meets specifications established in accordance with 111.70(e) and (g) [21 CFR 111.260(i)]
- the initials of the person performing each manufacturing step and the person responsible for verifying the weight or measure of each component used in the batch, and for verifying the addition of components to the batch [21 CFR 111.260(j)]
- documentation, at the time of performance, of packaging and labeling operations [21 CFR 111.260(k)]
- documentation at the time of performance that quality control personnel performed its duties (i.e. reviewed the batch production record) [21 CFR 111.260(l)]
- documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)] and
- Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)]