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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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M.D. Science Lab 7/15/14

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-17
July 15, 2014
 
Ralph W. Albrecht
President
M.D. Science Lab
2131 Blount Road
Pompano Beach, FL 33069
 
Dear Mr. Albrecht:
 
The Food and Drug Administration (FDA) conducted an inspection of your facility located in Pompano Beach, FL, at the above referenced address, from September 18, 2013 - October 03, 2013. During our inspection, we found that your firm packages, labels, and distributes dietary supplement products under your firm’s name, and that you have entered into agreements with contract manufacturers to manufacture these products. The inspection found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483 (FDA 483), Inspectional Observations, which listed a number of the violations that cause your Max Load and Max Size Male Enhancement dietary supplement products 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)] because they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements. 
 
You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Dietary Supplement CGMP Violations
 
1.    You failed to implement quality control operations in your packaging, labeling, and holding operations for producing your dietary supplement to ensure the quality of your dietary supplements, and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65. In addition, 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, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and must make and keep written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements, as required by 21 CFR 111.140(b)(2). 
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these 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 [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplement products into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
 
Although, your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1983) (explaining that an offense can be committed under the Act by anyone who has a “responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g), 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
You must establish a system of production and process controls to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). You must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations 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 111.105). Further, you must have documentation of the quality control personnel review and approval of release for any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)). However, your operations manager informed our investigator that you do not have procedures for quality control operations. 
 
We have reviewed your November 12, 2013, and March 3, 2014, responses. Your response dated March 3, 2014, includes an SOP for Quality Control Responsibilities (SOP 820.2). However, your responses are inadequate because your SOP does not include specific procedures for conducting a material review and disposition decision, including situations where a specification is not met, as required by 21 CFR 111.103 and 111.105. Further, you did not provide documentation to show that you implemented these procedures in your quality control operations. 
 
2.    You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements that your firm packages and labels, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g). During the inspection, your operations manager confirmed that your firm has not established specifications for the labels and packaging used with your dietary supplement products. 
 
We have reviewed your November 12, 2013, and March 3, 2014, responses, which state that you are creating a “Master Label File” and establishing labeling and packaging specifications. However, your responses did not provide any documentation to demonstrate you established packaging and labeling specifications for your packaged and labeled dietary supplements. We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
 
3.    You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403, and you failed to make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b). Specifically, during the inspection, our investigator observed the packaging and labeling of Max Load (Lot #1306049, 60ct, exp. 8/16). Your operations manager informed our investigator that your firm does not have written procedures for the packaging and labeling operations of your dietary supplements.
 
We have reviewed your November 12, 2013, and March 3, 2014, responses, in which you state that SOPs are currently being written to establish procedures for packaging and labeling your dietary supplement products. However, your responses did not provide a copy of your written procedures for your packaging and labeling operations. We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
 
4.    You failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging and/or labeling and distribution as dietary supplements are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, your operations manager informed our investigator that your firm has not established specifications for the products “Max Size and Max Load Caplets and Tablets, respectively” your firm receives in bulk for repackaging and labeling as dietary supplements.
 
We have reviewed your November 12, 2013, and March 3, 2014, responses, in which you state that SOPs are being written to ensure that the dietary supplement products you receive for packaging and labeling are “properly identified and are consistent with [your] Purchase Order.” However, your responses did not provide a copy of the product specifications that you established for the products you receive from your supplier for packaging and labeling. We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
 
5.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.  Specifically, your operations manager informed our investigator that your firm does not have written procedures for holding and distributing operations, as required by 21 CFR 111.453.
 
We have reviewed your November 12, 2013, and March 3, 2014, responses, in which you state that SOPs are currently being written to establish procedures for holding and distributing operations. However, your responses did not provide a copy of your written procedures for your holding and distributing operations. We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
 
6.    You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503, and you failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Your operations manager informed our investigator that you do not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515.
We have reviewed your November 12, 2013, and March 3, 2014, responses. Your responses did not address this deficiency.
 
7.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553.  Specifically, your operations manager informed our investigator that you have not established written procedures for the review and investigation of product complaints.
We have reviewed your November 12, 2013, and March 3, 2014, responses. Your responses did not address this deficiency.
 
8.    You failed to establish specifications for your dietary supplement labels (label specifications) and for packaging that may come in contact with your dietary supplements (packaging specifications), as required by 21 CFR 111.70(d). Specifically, your operations manager informed our investigator that you have not established specifications for the labels and packaging used with your dietary supplement products.
 
We have reviewed your November 12, 2013, and March 3, 2014, responses, in which you state that labeling and packaging specifications are being established. However, your responses did not provide a copy of your specification sheet for the labels and packaging you use in your packaging and labeling operations. We are therefore unable to determine the adequacy of your proposed corrective actions at this time.
 
9.    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 stated to our investigator that he does not collect samples of your dietary supplement products.
 
We have reviewed your November 12, 2013, and March 3, 2014, responses. Your responses did not address this deficiency.
 
This letter is not intended to be an all-inclusive list of 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 products are in compliance with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter and prevent their recurrence.  Failure to promptly correct these violations may result in enforcement action, such as seizure or injunction, without further notice.   
 
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 costs related to re-inspection. 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 costs related to re-inspection.
 
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the violations cited above, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions you have taken.  If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities.  If corrections and/or corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which these corrections will be completed. Your response should be comprehensive and address all violations included in this letter.  
 
Your response should be sent to Erica M. Katherine, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about the content of this letter, please contact Ms. Katherine at (407) 475-4731.
 
 
Sincerely,
/S/
Elizabeth W. Ormond
Acting Director, Florida District
 
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