WARNING LETTER
Uckele Health & Nutrition, Inc.
MARCS-CMS 540533 —
March 05, 2018
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Mr. Michael J. Uckele
Uckele Health & Nutrition, Inc.
Uckele Health & Nutrition, Inc.
5600 Silberhorn Highway
Blissfield
,
MI
49228
United States
Issuing Office:
Chicago District Office
United States
WARNING LETTER
FY18-HAFE6-04
March 6, 2018
VIA UPS
Mr. Michael J. Uckele, CEO
Uckele Health & Nutrition, Inc.
5600 Silberhorn Highway
Blissfield, MI 49228
Dear Mr. Uckele:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, Uckele Health and Nutrition, Inc. located at 5600 Silberhorn Highway, Blissfield, MI from September 12 through September 22, 2017. During the inspection of your firm, FDA identified a number of significant violations of FDA’s Current Good Manufacturing Practices (CGMP) in the Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplement Regulations, under Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These CGMP violations cause your 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)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You may find the Act and its implementing regulations through links on FDA’s homepage at
www.fda.gov
.
We’ve reviewed your written response, dated October 13, 2017, addressing our investigator’s observations noted on the FDA Form 483 issued to your facility at the conclusion of the inspection. We address your response below in relation to each dietary supplement CGMP violation.
Our inspection revealed the following violations:
1.
You failed to establish product specifications for each dietary supplement for the identity and purity of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you did not establish identity and purity specifications for your products Digestzyme Plus (lots 1940271 and 1995542), Apexenergetics (K-104) Histo- X 90 CT Caps (lot 2129590), BIO-M for Men 120’s Nutri GNX, Apexenergetics (K-99) Enzymix Pro (lot 1829595) and ANS Internal Facelift (lots 2208507 and 1987640).
We have reviewed your October 13, 2017 response wherein you provided a finished product specification sheet for BIO-M for Men 120’s Nutri GNX, as an example. We have determined that your response is inadequate. Specifically, for identity of the finished product, you state the specification as “light gray capsule.” Such a physical property of the capsule alone does not sufficiently describe the identity of your multi-ingredient finished product. Furthermore, for the purity specification you did not identify which portion of your multi-ingredient product is required to be 28.86 percent.
Once you have established finished product specifications for the identity and purity of these dietary supplements, you must verify that the specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75(c), and you must make and keep records in accordance with 21 CFR 111.95(b)(1).
2.
You failed to include the following required elements in your written master manufacturing record (MMR) for your Digestzyme Plus product, as required by 21 CFR 111.210:
A complete list of components to be used [21 CFR 111.210(b)];
An accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)];
The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)];
A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
A statement of the theoretical yield expected for each point, step, or stage of the manufacturing process to ensure the quality of the dietary supplement and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made. [21 CFR 111.210(f)];
A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label; [21 CFR 111.210(g)]
Written instructions, including the following:
o
Specifications for each 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 111.210(h)(1)];
o
Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
o
Specific actions necessary to perform and verify points, steps, or stages 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 111.210(h)(3)];
o
Special notations and precautions to be followed; [21 CFR 111.210(h)(4);]
o
Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)]
We have reviewed your response, dated October 13, 2017; and have determined your response to be inadequate. You provided a MMR SOP; however, your response failed to include the actual MMR with the included change control process as noted in your response.
3.
You failed to prepare a batch record (BPR) every time you manufactured a batch of a dietary supplement as required by 21 CFR 111.255. Specifically, the batch production record for Digestzyme Plus (lots 1940271 and 1995542) failed to contain the following information for a batch record as required in 21 CFR 111.260:
The identity of equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b).
The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross reference to records, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c).
The unique identifier that you assigned to each component, as required by 21 CFR 111.260(d).
The identity and weight or measure of each component used, as required by 21 CFR 111.260(e).
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f)
The actual results obtained during the monitoring operations, as required by 21 CFR 111.260(g).
The results of any testing or examination performed during the batch production, or a cross-reference to such results, as required by 21 CFR 111.260(h).
Documentation of the manufacture of the batch at the time of performance, as required by 21 CFR 111.260(j), including:
o
The date on which each step of the MMR was performed, as required by 21 CFR 111.260(j)(1).
o
The initials of the persons performing each step, as required by 21 CFR 11.260(j)(2), including:
§
The initials of the person responsible for weighing or measuring each component used in the batch, as required by 21 CFR 111.260(j)(2)(i).
§
The initials of the person responsible for verifying the weight or measure of each component used in the batch, as required by 21 CFR 111.260(j)(2)(ii).
§
The initials of the person responsible for adding the component to the batch, as required by 21 CFR 111.260(j)(2)(iii).
§
The initials of the person responsible for verifying the addition of components to the batch, as required by 21 CFR 111.260(j)(2)(iv).
Additionally, your BPR’s for Apex Histo X (K-104) (Batch FHP-2129588-1), Bio M for Men Bulk (Batch HP-2101261-1), Apexenergetics Enzymix Pro (K-99) (Batch HP-1829593-1), Internal Facelift (Batches FHP-1699690-1 and FHP-2208505-1) fail to include the following:
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f);
Documentation, at the time of performance, of the initials of the persons performing each step, including the initials of the person responsible for verifying the weight or measure of each component used in the batch, as required by 21 CFR 111.260(j)(2)(ii).
We have reviewed your response, dated October 13, 2017. You state that you have revised your SOP to ensure that “no batch of dietary supplement will be manufactured without a batch production record.” We will evaluate the adequacy of the implementation of your corrective action at the next inspection.
4.
Your quality control personnel failed to comply with 21 CFR 111.123(b)(1) because they approved and released for distribution a dietary supplement containing components that did not meet their identity specifications. Specifically, your Apexenergetics (K-104) Histo-X capsules (lot 2129590), were released by quality control on June 30, 2017, despite two components, Nettle Leaf Extract 4:1 Powder and Quercetin Dihydrate 95% Granular, that failed identity testing.
Based on the evidence collected during the inspection it appears that third party testing is performed at
(b)(4)
for confirmation of identity. The sample material analysis stated, “This test sample, Nettle Leaf Ext (Stryka) (SB16-H071287), is not consistent with the chromatographic profile of the reference samples of Urtica dioica L. [Urticaceae], used above. This test sample, Nettle Leaf Ext (Stryka) (SB16-H071287), is not characteristic of an extract derived from Urtica dioica L. [Urticaceae] leaf.”
Additionally, the analysis for the sample stated for Quercetin Dihydrate (Jiaherb) (CHPS-A-602164), test Sample, Quercetin Dihydrate (Jiaherb) (CHPS-A-602164) is not consistent with the chromatographic profile of the reference samples of Sophora japonica.
In your response dated October 13, 2017, you provided results of the materials in question achieving again a nonconformance result. You also state that you are working on sourcing a new supplier for the Nettle Leaf Extract. You do not state in your response what action(s) you have taken to correct, and prevent a recurrence of, the nonconformance result.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the the violations cited in this letter. Failure to do so may result in an enforcement action by FDA without further notice, including, without limitation, seizure and/or injunction.
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation that would assist us in evaluating your corrective actions. If you cannot complete all corrective actions within fifteen working days, you should explain the reason for your delay and state the date by which you will correct any remaining violations.
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 FD&C 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 FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to Dr. Byron Ho, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Dr. Byron Ho at (313) 393-8262 or email to
byron.ho@fda.hhs.gov
.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Office of Human and Animal Food Operations
Division East 6
Content current as of:
09/25/2018
Regulated Product(s)
Dietary Supplements
Food & Beverages