Inspections, Compliance, Enforcement, and Criminal Investigations

LiquidCapsule Manufacturing, LLC 5/15/15

  

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-15-25
May 15, 2015
 
Mr. Frederick H. Miller
President and Owner
LiquidCapsule Manufacturing, LLC
9216 Palm River Rd. Suite 203
Tampa, FL 33619-4479
 
Mr. Frederick H. Miller
President and Co-Owner
Health International Products, Inc.
9216 Palm River Rd. Suite 203
Tampa, FL 33619-4479
 
Dear Mr. Miller:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection at your dietary supplement firms, LiquidCapsule Manufacturing, LLC, Inc. and Health International Products, Inc. located at 9216 Palm River Rd, Tampa, Florida from September 22, 2014 to October 20, 2014. You informed our investigator that your firm, LiquidCapsule Manufacturing, LLC manufactures, packs, labels, and warehouses dietary supplement products, which are distributed by your firm, Health International Products, Inc. under the name, Health International Products, Inc. 
 
Our inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your EnergyXcentric dietary supplement products (30 and 60 capsules), 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 products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. During the inspection, we also obtained labels for your product, EnergyXcentric Dietary Supplement in three packaging styles. Review of the labels demonstrate that your products are misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and implementing regulations on our website at www.fda.gov.
 
Specifically, during our inspection, our investigators observed the following violations, which were noted on form FDA 483 Inspectional Observations, issued to you on October 10, 2014. We received your written response dated November 7, 2014 to the Form FDA 483. We are unable to evaluate the adequacy of your response because you did not provide documentation of your proposed corrective actions.  
 
Dietary Supplement CGMP Violations
 
1.    You failed to establish component specifications that are necessary to ensure that specifications for the purity and strength of dietary supplements manufactured using the components are met for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(2).  Specifically, you failed to establish specifications for the following components used to manufacture your finished dietary supplement product EnergyXcentric capsules:
  • Lot # B022X, untimed red caffeine pellets, used in the manufacture of EnergyXcentric capsules, lot #s 13H001, 14A001, and 14H002.
  • Lot #B023X, timed yellow caffeine pellets, used in the manufacture of EnergyXcentric capsules, lot #s 13H001, 14A001, and 14H002.
  • Lot #10101-326A1, conjugated linoleic acid (b) (4) used in the manufacture of EnergyXcentric capsules, lot #s 14A001, and 14H002.
Once you have established component specifications and before using a 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 received your November 7, 2014 response letter, but we are unable to evaluate the adequacy of your response. You state in your letter, “Liquidcapsule will establish specifications for the purity, strength and composition of each component used in products,” and that “Liquidcapsule is in the process of creating the Specification for each component.” We are unable to evaluate the adequacy of your proposed corrective actions because you did not provide us with documentation of your specifications nor did you provide us with a timeline of when these specifications will be established.
 
2.    You failed to maintain documentation of how you qualified your suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificate of analysis through confirmation of the results of the suppliers’ test or examinations, as required by 21 CFR 111.75(a)(2)(ii)(C).  During the inspection, you stated that you use your “SOP Number OC-2100 Vendor Qualification Program” as a written procedure to qualify your suppliers,  which indicates that you withdraw samples from raw material containers for submission to an approved contract testing lab so that test results can be compared with the vendor’s Certificate of Analysis. However, you were unable to provide complete documentation for how you qualified your suppliers for the following components used in the manufacture of your EnergyXcentric capsules:
  • Timed yellow caffeine pellets used in the manufacture of EnergyXcentric capsules, lot #s 13H001, 14A001, and 14H002. The same lot of raw material was used in each of these three lots of finished product and a document for the Vendor Qualification Program was provided. However, while the document identified information from the vendor’s CofA, the document does not appear to be complete as it does not include information regarding how you confirmed the results of your supplier’s tests or examinations.
  • FD&C Red No. 40 granular used in the manufacture of EnergyXcentric capsules, lot #s 13H001, 14A001, and 14H002.   During the inspection, you informed us that you do not have vendor qualification worksheets for this component.
  • Conjugated linoleic acid used in the manufacture of EnergyXcentric capsules lot #s 14A001and 14H002.  During the inspection, you informed us that you do not have vendor qualification worksheets for this component.
We received your written response dated November 7, 2014, but your response cannot be evaluated because of the lack of supporting documentation.
 
3.    You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, 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). While your finished product specification sheet for your EnergyXcentric 60 Multi-phase capsules and 30 Multi-phase capsules included certain micro and visual/physical specifications, you did not establish all of the product specifications required by 21 CFR 111.70(e).   The specifications you provided for your EnergyXcentric Capsules Caffeine (100mg) 30ct/60ct dietary supplement product did not include specifications for identity, purity, strength, and composition, as required by 21 CFR 111.70(e).
 
Once you establish product specifications, for every finished batch, or for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan, you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, 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, as required by 21 CFR 111.75(c). 
 
4.    Your quality control personnel have failed to reject dietary supplements that did not meet specifications under 111.70(e), as required by 21 CFR 111.75(a)(2)(ii)(E).  Although your firm has not established all specifications as required by 21 CFR 111.70(e), you do appear to have established certain specifications for strength for your vitamin B12 component which is used in the manufacture of your EnergyXcentric product, and your firm had a third party laboratory analyze such component for assay, which reveals strength . For example: 
  • You provided an assay result for Vitamin B12 from a third party laboratory. Your firm used this lot of Vitamin B12 to manufacture lot#13H001 EnergyXcentric with a specification for vitamin B12 of (b)(4); however, the test results document a result of (b)(4). The lot was released by your quality control personnel on July 7, 2014.
  • You provided an assay result for Vitamin B12 from a third party laboratory. You used this lot of Vitamin B12 to manufacture lot #14A001 EnergyXcentric with the specification for vitamin B12 of (b)(4); however, the test results document a result of (b)(4). The lot was released by your quality control personnel on March 3, 2014.
 
5.    Your Quality Control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, on July 7, 2014, your quality control personnel approved for release your EnergyXCentric dietary supplement product (30 capsules), batch #13H001, whose label states that diacylglycerol oil is an ingredient in this product. However, during our inspection, you stated that you no longer use diacylglycerol oil in your EnergyXCentric product and your quality control personnel confirmed that your firm had discontinued using this ingredient in 2012. 
 
6.    You failed to prepare and follow a written master manufacturing record 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). Specifically, during our inspection, your manager informed our investigator that MMRs were not implemented prior to the creation of BPRs. You must prepare a MMR prior to the preparation of a BPR so that your BPR accurately follows the appropriate MMR, as required by 21 CFR 111.255(c). 
 
However, the in-process mixing times documented in your BPRs did not accurately follow the mixing times specified in your MMRs. Specifically:
  • EnergyXcentric lot #14A001 was mixed for (b)(4) when the BPR states to mix for (b)(4) 
  • EnergyXcentric lot #14H002 was mixed for (b)(4) when the BPR states to mix for (b)(4), and,
  • EnergyXcentric lot #13H001 was mixed for (b)(4) when the BPR states to mix for (b)(4)
We note that your quality control personnel must conduct a material review and make a disposition decision if a batch deviates from the MMR, including when any step established in the MMR is not completed and including any deviation from specifications, as required by 21 CFR 111.113(a)(2).
 
7.    Your batch production record failed to include complete information relating to the production and control of each batch of finished dietary supplements, as required by 21 CFR 111.255(b). Your Batch Production Record must include: the unique identifier that you assigned to each component used, as required by 21 CFR 111.260(d), and an actual or representative label or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record, as required by 21 CFR 111.260(k)(2). Specifically:
  • The batch production record for EnergyXcentric, lot #13H001 does not identify the unique identifier of conjugated linoleic acid (CLA) that was used in production of the batch, as required by 21 CFR 111.260(d).
  • The batch production record EnergyXcentric, lot #14A001 does not document the labeling of EnergyXcentric 2 capsule packs, as required by 21 CFR 111.260(k)(2).
We received your November 7, 2014 written response but your response cannot be evaluated because of the lack of supporting documentation. 
 
Misbranded Dietary Supplements:
 
1.    Your EnergyXcentric, 2 day supply, 30 capsule count and 60 capsule count products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.4(g). For example, the formula for this product includes Red Un-Timed Caffeine Stock Pellets as an ingredient, which according to the ingredient list of the Pellets, contains the following ingredients that are not identified on the EnergyXcentric labels: talc, shellac, povidone, and FD&C Red #3. 
 
2.    Your EnergyXCentric, 30 capsule count, and EnergyXCentric, 2 day supply, products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]  because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The immediate container label states that the serving size is 1 capsule but the Suggested use states to take “one or two” capsules. As such, the serving size should be 2 capsules. We reviewed an additional outer carton retail box for your 30 capsule count product which does not contain this deviation; however, it is unclear whether you use the additional outer carton label. We note that your labeled instructions should be consistent on all labels.
 
3.    Your EnergyXCentric, 30 capsule count, product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g). We reviewed an additional outer carton retail box for your 30 capsule count product which does not contain this deviation; however, it is unclear whether you use the additional outer carton label. We note that the statement of identity should be consistent on all labels.
 
4.    Your EnergyXCentric, 2 day supply, product is misbranded within the meaning of 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents (“2 day supply”) is not listed in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure, as required by 21 CFR 101.105(a).
 
5.    Your EnergyXCentric capsules product is misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading.  Specifically, the label of your EnergyXCentric capsules product states that diacylglycerol oil is an ingredient in your product.  However, during our inspection, you stated that you no longer use diacylglycerol oil in your EnergyXCentric product and your quality assurance staff member confirmed that your firm had discontinued using this ingredient in 2012.
 
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or 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. You are responsible for ensuring that your firm operates in compliance with the Act and applicable FDA regulations, including dietary supplement CGMP regulations (21 CFR Part 111).
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. 
 
In addition to the violations discussed above, we have the following additional comments:
 
You stated to our investigator that your firm uses shared equipment in the manufacture of your dietary supplements; you further stated that you do not currently manufacture any products with allergens. We note that you have manufactured products containing krill oil and other fish oils in the past. You did not demonstrate during the inspection that you have an adequate cleaning and sanitizing program to eliminate any potential allergens you may introduce into your firm or may have introduced in the past during manufacturing practices. All equipment and utensils you use must be maintained to protect components and dietary supplements from being contaminated by any source, as required by 21 CFR 111.27(a)(3)(v).
 
Additionally, during the inspection, we were provided with “SOP Number: MPC-5600 Calibration of Instruments” which states that scales used in production are to be calibrated daily. The calibration log for several production scales were obtained and those logs state that calibration is to occur every day before state of production. We note that you must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b). 
 
You must also establish and follow written procedures for fulfilling the requirements of Subpart D (Equipment and Utensils) of 21 CFR Part 111, including but not limited to written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary ingredient, as required by 21 CFR 111.25(a).  
 
Your firm assigns an expiration date of three years from the date of packaging of your products. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. 
 
Further, your EnergyXcentric dietary supplement product (30 capsules) appears to have both an immediate container stick-on label and an outer retail box. We note that your MMR must include a description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).   In addition, your BPR must include documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k).
 
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 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 re-inspection 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, FDA may assess fees to cover any reinspection-related costs.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Your response should be sent to Carla A. Norris, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Norris can be reached at 470-475-4730 or Carla.Norris@fda.hhs.gov.
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District

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