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WARNING LETTER

Morhaim Pharmalab, Inc. MARCS-CMS 514515 —


Recipient:
Morhaim Pharmalab, Inc.


United States

Issuing Office:
Florida District Office

United States


  

Department of Health and Human Services logo

 
 
U.S. Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION

WARNING LETTER

FLA 17-09

May 16, 2017


Wilsce Santiago de Quiroz, President
Morhaim Pharmalab, Inc.
6990 NW 82nd Ave
Miami, FL 33166

Dear Ms. Santiago de Quiroz:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 6990 NW 82nd Ave., Miami, FL 33166, from September 26, 2016 through September 30, 2016. The inspection revealed serious violations of FDA’s 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). These violations cause your Vital Procollagen dietary supplement product 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 the dietary supplement has been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements. Our investigators’ observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of the inspection on September 30, 2016.

Additionally, our investigators collected and reviewed samples of the labeling of your dietary supplement product during the inspection of your facility.  Based on our review, your Vital Procollagen product is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA’s labeling regulations under 21 CFR Part 101.  You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.

The inspection revealed the following significant violations:

Dietary Supplement CGMP Violations

1. 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. Once you have established these procedures, you are required to keep such written procedures and all documentation of their performance, as required by 21 CFR 111.140(b)(1).

Specifically, you have not established and maintained written quality control operations procedures related to material review, disposition decisions, approval or rejection of a finished dietary supplement for distribution, and product complaint investigations for the Vital Procollagen dietary supplement manufactured by your firm. You have not established a quality system that reviews all receiving records, requires material review and disposition decisions, approves or rejects in-process specifications, and approves or releases materials from quarantine before they are used in the manufacturing process of Vital Procollagen dietary supplement manufactured by your firm or in returned dietary supplements.

We have reviewed your response letter, dated October 24, 2016, in which you state that you will create and keep written records for processes and procedures for the responsibilities of the quality control operations.  However, we cannot evaluate the adequacy of your response because you did not provide the required written procedures for the responsibilities of the quality control operations for our review.

This is a repeated observation listed on the two previous Form FDA 483 reports, Inspectional Observations, issued to your firm on February 29, 2012 and November 2, 2012.

2. You failed to establish component specifications, as required by 21 CFR 111.70(b)(1) and (2), for your Vital Procollagen dietary supplement product.  Specifically, you must establish an identity specification for each component that you use in the manufacture of your Vital Procollagen product.  You must also establish component specifications that are necessary to ensure that specifications for the identity, purity, strength and composition of your Vital Procollagen product manufactured using the components are met.

Once you have established component specifications and before using each component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing, and you must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).

We have reviewed your response letter, dated October 24, 2016.  You state that you will establish component specifications for identity, purity, strength, and composition and will maintain records of these specifications on site. However, we cannot evaluate the adequacy of your response because you did not provide a copy of the component specifications. You also state in your response that you will require your suppliers to provide you with the laboratory test results for each lot of raw material you purchase.  As noted above, 21 CFR 111.75(a)(1) requires you to verify the identity of any component that is a dietary ingredient prior to its use unless you petition the agency for exemption.

This is a repeated observation listed on the two previous Form FDA 483s, Inspectional Observations, issued to your firm on February 29, 2012 and November 2, 2012.

3. You failed to establish product specifications for each dietary supplement that you manufacture 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 to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).

4. You failed to establish specifications for the dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d). Specifically, it was observed during the inspection that your firm did not have specifications for labels and packaging.

5. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of 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). Once you establish a master manufacturing record, it must conform to the requirements of 21 CFR 111.210.

Specifically, you were unable to provide any MMR documentation for your Vital Procollagen dietary supplement manufactured by your firm upon our request during the inspection.  Further, during the inspection, you stated that you have changed the formulation but do not maintain change records.

We have reviewed your response letter, dated October 24, 2016, in which you state that, you will be responsible for preparing, writing and compiling a Master Manufacturing Record (MMR) for Vital Procollagen and other dietary supplements you may produce.  However, we cannot evaluate the adequacy of your response because you did not provide us with an MMR for Vital Procollagen for our review.

This is a repeated observation listed on the previous Form FDA 483 report, Inspectional Observations, issued to your firm on November 2, 2012.

6. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a).  Specifically, you were unable to provide any batch record documentation for any batch of Vital Procollagen dietary supplement manufactured by your firm upon our request during the inspection.

We have reviewed your response letter, dated October 24, 2016.  In your response you state that you will prepare a batch manufacturing record every time a production run is made for Vital Procollagen, or any other dietary supplement you may produce.  However, we cannot evaluate the adequacy of your response because you did not provide a copy of a batch production record for our review.

7. You failed to establish written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553.    Specifically, you have not established written procedures for product complaints related to Vital Procollagen dietary supplement manufactured by your firm. Requirements for the review and investigation of product complaints can be found under 21 CFR 111.560. 

We have reviewed your response letter, dated October 24, 2016, in which you state that you will establish written procedures for receiving and documenting product complaints from consumers, and that this will include the processing of consumer complaints, review and approval of related complaint investigations, subsequent findings, and follow up actions.  You also state that complaints will be reviewed by qualified in house medical staff.  However, we are unable to evaluate the adequacy of your response because you did not provide documentation of your written procedures for the handling of product complaints.

This is a repeated observation listed on the previous Form FDA 483 report, Inspectional Observations, issued to your firm on November 2, 2012.

8. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.  Specifically, you have not established and maintained written procedures for all holding and distributing operations of Vital Procollagen dietary supplement manufactured by your firm.  Your written procedures for holding and distributing operations must include procedures for complying with all relevant parts of 21 CFR Part 111, Subpart M, including requirements about: holding components, dietary supplements, packaging, and labels (see 21 CFR 111.455); holding reserve samples of dietary supplements (see 21 CFR 111.465); and distributing dietary supplements (see 21 CFR 111.470).  Further, once you establish written procedures for your holding and distributing operations, you must make and keep records of them, as required by 21 CFR 111.475(b)(1).

We have reviewed your response letter, dated October 24, 2016, in which you state that you will establish written procedures for holding and distribution of Vital Procollagen and other dietary supplements you may produce or sell or distribute and that you will train staff on these procedures and maintain records of training.  However, we are unable to evaluate the adequacy of your response because you did not provide your written procedures for the holding and distributing of Vital Procollagen and other dietary supplements you may produce, sell or distribute.

This is a repeated observation listed on the previous Form FDA 483 report, Inspectional Observations, issued to your firm on November 2, 2012.

9. The plumbing in your physical plant was not adequate to properly convey sewage and liquid disposable waste from your physical plant, as required by  21 CFR 111.15(f)(2). Specifically, the waste drainage system at the hand wash and equipment wash sinks location in the processing room where dietary supplement products are manufactured were noted to be plumbed into a plastic container used as a sump basin, that collects accumulated waste water from the sinks, prior to being removed by a submersible sump pump to a waste water line once an unspecified amount of water has accumulated. Further, the waste lines were noted to be dripping onto the floor under the sink which could lead to cross-contamination of the manufacturing operation due to foot traffic.

We have reviewed your response letter, dated October 24, 2016, in which you state the waste water and sewage drainage system at the hand washing and processing equipment washing sinks will be connected to the waste water piping in the physical plant.  However, we are unable to evaluate the adequacy of your response because you did not provide documentation that you made needed corrections to your waste water and sewage drainage system.

10. Your firm failed to establish and use appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use, as required by 21 CFR 111.30(e). You must also make and keep documentation of such controls, as required by 21 CFR 111.35(b)(6). Specifically, you have not established and implemented controls to ensure that equipment such as the mixer with stainless steel paddles that your firm uses in the manufacture of Vital Procollagen dietary supplement functions in accordance with its intended use. You have not determined if this mixer is capable of operating satisfactorily within the operating limits required by the process.

We have reviewed your response letter, dated October 24, 2016, in which you state that you will establish quality control operations for equipment, instruments, and controls and will implement quality control systems to establish operations for all manufacturing equipment. However, we are unable to evaluate the adequacy of your response because you did not provide us with documentation of your controls for all manufacturing equipment and instruments.

This is a repeated observation listed on the previous Form FDA 483 report, Inspectional Observations, issued to your firm on November 2, 2012.

11. You failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.16.  Specifically, you have not established written procedures for cleaning the facility.

We have reviewed your response letter, dated October 24, 2016, in which you state that you will “establish written procedures, frequency, and records for cleaning the physical plant to comply as a food handling/distribution facility and FDA GMP requirements CFR Title 21 Part 111.”  However, we are unable to evaluate the adequacy of your response because you failed to provide documentation of your written procedures.

This is a repeated observation listed on the two previous Form FDA 483 reports, Inspectional Observations, issued to your firm on February 28, 2012, and November 2, 2012.

12. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503.  Specifically, your firm has not established written procedures for returned dietary supplement operations for your Vital Procollagen product.

We have reviewed your response letter, dated October 24, 2016, in which you state that you will establish written procedures and operations for returned dietary supplements, and that all dietary supplements that are returned will be documented, and if unopened, not damaged, and within expiration date, they will be evaluated according to a written procedure to determine if the product can be put back into inventory for resale. Further, you state that if the products do not meet these criteria you will not reuse, resell, or remanufacture the returned products and they will be documented and destroyed. You also state that all records will be maintained on premises at Morhaim Pharmalab. We are unable to evaluate the adequacy of your response because you failed to provide us with documentation demonstrating that you have established the procedures stated above.

This is a repeated observation listed on the previous Form FDA 483 report, Inspectional Observations, issued to your firm on November 2, 2012.

Dietary Supplement Misbranding

13. Your Vital Procollagen product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. For example, your product lists Other Ingredients of Natural Piña Colada Flavor. This is not a common or usual name.

14. Your Vital Procollagen product is misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically,

• The Supplement Facts label lists “Calories from Fat” as “0.” Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 21 CFR 101.9(c), must not be declared, in accordance with 21 CFR 101.36(b)(2).
• The Supplement Facts label lists a quantitative amount for Calories and a % Daily Value for magnesium that are in the incorrect increments.  And not in accordance with 21 CFR 101.36(b)(2)(ii)(A), 101.9(c), and 101.36(b)(2)(iii)(C).
• The label fails to place a heavy bar after the last (b)(2)-dietary ingredient as required by 21 CFR 101.36(e)(6).

15. Your Vital Procollagen product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

16. Your Vital Procollagen product is misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

We acknowledge receipt of your written response dated October 24, 2016. In reviewing your response we noticed that you failed to provide supporting documentation that the corrective actions identified were implemented. We also acknowledge that Morhaim Pharmalab is voluntarily halting production of products at its facility in an effort to fully comply with FDA regulations and GMPs by February 15, 2017. Moreover, we acknowledge that Morhaim Pharmalab has decided to cease all production at Morhaim Pharmalab and utilize a GMP qualified co-packer for production of the Vital Procollagen until such time that your firm becomes compliant for production.

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the FD&C Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction. 

We also offer the following comments regarding the labeling of your Vital Procollagen product:

• If the Natural Piña Colada Flavor contains coconut, which is a flavor expected in a Piña colada, that allergen must be declared as required under section 403(w) of the Act [21 U.S.C. 343(w)].
• Your Vital Procollagen product label contains the statement “30 Day Supply”. However, the label also indicates the product container provides 32 servings and that one serving is to be taken per day.

You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence.  In your response, include documentation that would assist us in evaluating your corrective actions.  If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining violations.

Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the FDA’s cost for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, the FDA may assess fees to cover any reinspection-related costs.

Your written response should be sent to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200 Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mr. Morris at (407) 475-4741.


Sincerely,
/s/
Susan M. Turcovski
Director, Florida District