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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Milk Specialties Global - Wautoma 12/19/11

  

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 

 

                                                                                                         
December 19, 2011
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                          
Refer to MIN 12 - 16
 
 
Trevor Tomkins, Ph.D.
Chief Executive Officer
Milk Specialties Global
260 S. Washington Street
Carpentersville, Illinois 60110
 
Dear Dr. Tomkins:
 
An inspection of your facility located at 248 Chicago Road, Wautoma, Wisconsin, was conducted by our investigator from the Food and Drug Administration (FDA) on July 27-29 and August 2, 2011. This inspection found that your firm manufactures dietary supplements in capsule, tablet, and powder blend dosage forms. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (CGMP) regulations under Title 21, Code of Federal Regulations, Part 111 (21 CFR 111).  The violations cause products manufactured in 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 dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements in 21 CFR 111. You may find the Act and the CFR through links on FDA’s home page at www.fda.gov. These observations were presented to you on a Form FDA 483, List of Inspectional Observations, at the conclusion of the inspection.
 
The inspection revealed the following violations:
 
1.    Your firm failed to establish product specifications for each dietary supplement you manufacture for the identity, purity, strength, and composition of the finished batch of dietary supplement, as required by 21 CFR 111.70(e).  Specifically, you were not able to show established product specifications for the identity, purity, strength, and composition of the following finished dietary supplement products:
  • primaForce Proliver Capsules, lot #005449
  • Dr. Mercola Vitamin K2, lot #105421
  • Active Women’s Multivitamin/Multimineral, lot #107740
We reviewed your response dated August 19, 2011, and found it to be inadequate. Your response did not include documentation to show that you have corrected this deviation. 
 
2.    Your firm failed to determine whether you met established product specifications for identity, purity, strength and composition prior to distribution, to comply with 21 CFR 111.73.  Specifically, you failed to verify that your finished dietary supplement batch of Cremagnavol dietary supplement, lot #105425 met product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c).  Specifically, you failed to select one or more established specifications for identity, purity, strength, or composition that, if tested or examined on the finished batches, would verify that your production is producing a dietary supplement that meets all (or all of the non-exempt) product specifications, as required by 21 CFR 111.75(c)(1), and failed to conduct appropriate tests or examinations to determine compliance with the selected specifications, as required by 21 CFR 111.75(c)(2).    
 
Your August 19, 2011, response states Cremagnavol, lot #105425, has been sent to a contract laboratory for testing. Your response is inadequate in that you do not include documentation of your selection of one or more specifications for the identity, purity, strength, and composition of the finished product or documentation of testing, examinations, or any exemptions. 
 
3.    Your firm failed to establish specifications for purity, strength, and composition for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b)(2).  Our review of the raw material specification sheet and raw material release form for milk thistle seed extract 80%, lot #20091019, calcium carbonate, lot #632603, and vitamin/mineral premix 25%, lot #61107048, revealed that you lacked these specifications. 
 
Your August 19, 2011, response states you will create raw material/component specifications for each component received. Your response is inadequate in that you have not provided any documentation to support that you are establishing these specifications. 

4.   Your batch production records (BPRs) did not include complete information relating to the production and control of the batch of your Immune Support, lot #107724, and HPF Women’s Multi, lot #107740, dietary supplement products, as required by CFR 111.255(b).  Specifically, your BPRs did not include the actual results which were obtained during the monitoring of the operation (i.e., encapsulating, tableting) associated with (b)(4) inspection of capsules collected in (b)(4) to determine if capsules were dented or broken or tablets were defective in any way, as required by 21 CFR 111.260(g). 

Your August 19, 2011, response states you have implemented a process deviation sheet to record process deviations. Additionally, you state a log will be maintained to record individual events to observe possible trends. You state training has occurred and the log is being maintained. Your response is inadequate in that you have not provided documentation to support the training or implementation of the deviation procedure and log.
 
5.    Your firm failed to make and keep documentation of any material review and disposition decision and follow-up, as required by 21 CFR 111.140(b)(3). Specifically, our review of the batch record for the Prevagen dietary supplement, lot #101007 showed that you (b)(4) of the product.  However, you did not provide documentation of any material review and disposition decision and follow-up for this in-process adjustment to the component.  You must document material review and disposition decisions and follow-up in accordance with the requirements of 21 CFR 111.140(b)(3), including the requirements that you:  identify the specific deviation or the unanticipated occurrence, 21 CFR 111.140(b)(3)(i); describe your investigation into the cause of the deviation from the specification or the unanticipated occurrence, 21 CFR 111.140(b)(3)(ii); evaluate 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); identify the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence, 21 CFR 111.140(b)(3)(iv); explain what you did with the component, dietary supplement, packaging, or label, 21 CFR 111.140(b)(3)(v); and explain 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).
 
Your August 19, 2011, response states you have implemented a process deviation sheet to record process deviations. Additionally, you state a log will be maintained to record individual events to observe possible trends. You provided copies of a new log to our investigator during the inspection. You state training has occurred and the log is being maintained. However, your response is inadequate in that you have not provided documentation to support the training or implementation of the deviation procedure and the log that you provided to our investigator did not contain all of the required elements listed above.
 
This letter is not intended to be an all-inclusive list of violations at your facility and does not represent a comprehensive review of all of the products manufactured by your firm. It is your responsibility to ensure that your establishment and all products manufactured by your firm are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations cited above may result in enforcement action, including seizure or injunction, being initiated by FDA. 
 
We also note that your firm’s reserve samples do not appear to consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications, as required by 21 CFR 111.83(b)(4). Specifically, you kept (b)(4) of the Vitamin K-2 product, lot #105241, as a reserve sample. (b)(4) of this product equals approximately (b)(4) of product. However, the amount of this reserve sample does not consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specification. Your lab manager told our investigator that (b)(4) of product was necessary to complete microbial testing. 
 
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
 
Your reply should be directed to Compliance Officer Melissa I. Michurski at the address indicated in the letterhead. Ms. Michurski may be reached at (612) 758-7185.
 
Sincerely,
/S/
Elizabeth A. Waltrip
Acting Director
Minneapolis District