WARNING LETTER
Premium Production LLC
MARCS-CMS 579705 —
July 29, 2019
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Elizabeth Cummings
Recipient Title
Owner
Premium Production LLC
786 E. Venture Dr.
Saint George
,
UT
84790-7899
United States
Issuing Office:
Division of Human and Animal Food Operations West IV
1 Denver Center, Building 20
Denver Federal Center
Denver
,
CO
80225-0087
United States
July 29, 2019
WARNING LETTER
Via UPS Overnight
Ref: # HAF4W(DEN)-19-08-WL
Elizabeth Cummings, Owner
Premium Production LLC
786 E. Venture Dr.
Saint George, UT 84790-7899
Dear Ms. Cummings:
From February 6 through February 8, 2019, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 785 E. Venture Dr., Saint George, Utah. The inspection revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).  These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.  You may find the Act and FDA regulations through links on FDA’s website at
www.fda.gov
.
We acknowledge receipt of your response to the FDA-483, Inspectional Observations, dated February 20, 2019, and we address your responses below.
The dietary supplement products you manufacture are adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C.
§ 342(g)(1)] because the products have been manufactured under conditions that do not meet CGMP regulations for dietary supplements, 21 CFR Part 111, as follows:
You failed to establish specifications for any 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, as required by 21 CFR 111.70(a).  Specifically, you have no in-process, raw material, or finished product specifications.
You must establish the following specifications for the dietary supplements you manufacture:
Specifications for each component that you use in the manufacture of a dietary supplement, including:
Identity specifications (21 CFR 111.70(b)(1));
Component specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and
Specifications that establish the limits on those types of contamination that may adulterate or 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(b)(3).
In-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements, as required by 21 CFR 111.70(c)(1).
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).
Once you have established the specifications as required by 21 CFR 111.70, you must take specific actions to determine whether the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75.  You must also ensure any tests and examinations 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 all activities relating to such specifications, in accordance with 21 CFR 111.95.
We have reviewed your response dated February 20, 2019, which states that you will establish and implement product specifications for the identity, purity, strength, composition, and limits on contamination that may adulterate or lead to adulteration of the finished dietary supplement.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established and implemented the required specifications.
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. Specifically, you have no written procedures for the responsibilities of the quality control operations.
Once you have established your quality control written procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65.
We have reviewed your response dated
February 20, 2019, which states that you will establish and implement various written procedures for your quality control operations.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established and implemented written procedures for your quality control operations.
You failed to prepare and follow a written master manufacturing record for each unique formulation of your dietary supplements 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, you do not have written master manufacturing records for any of the dietary supplements you manufacture.
We have reviewed your response dated
February 20, 2019, which
states that you will establish and implement a written master manufacturing record within 60 days that will include specific steps in the manufacturing process to ensure the quality of each formulation, and that it will be packaged and labeled as specified in the master manufacturing record.  You also state you will establish controls and procedures to ensure that each batch meets the specifications identified in the master manufacturing record.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established and implemented written master manufacturing records in accordance with the requirements under 21 CFR 11.210 for your dietary supplement products.
Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and in accordance with 21 CFR 111.260.  Specifically, your BPRs did not include the following information:
The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
The date and time of the 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 [21 CFR 111.260(c)];
The unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)];
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
Documentation, at the time of performance, of the manufacture of the batch, of the initials of the persons performing each step, including:
The initials of the person responsible for weighing or measuring of each component [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 [21 CFR 111.260(j)(2)(ii)];
Documentation, at the time of performance, of packaging and labeling operations, including an actual or representative label, or cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR111.260(k)(2)];
Documentation, at the time of performance, that quality control personnel:
Reviewed the batch production record [21 CFR 111.260(l)(1)];
Approved and released, or rejected, the batch for distribution [21 CFR 111.260(l)(3)];
Approved and released, or rejected, the packaged and labeled dietary supplement [21 CFR 111.260(l)(4)].
We have reviewed your response dated
February 20, 2019, which states that you will establish and implement a batch production record that will include the identity of equipment and processing lines used in manufacturing; date and time of maintenance, cleaning and sanitation of equipment or cross-reference to the records; a unique identifier that will be assigned to each component, packaging and label used in the process; a statement verifying the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing; initials for performance and verification of weight/measure and addition of components; documentation of packaging and labeling operations; representative label, label reconciliation, unique identifiers of packaging and labeling; and documentation of quality control review and disposition. We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have prepared batch production records for your dietary supplement products that include the required elements.
You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403.  Specifically, you do not have any written procedures for your packaging and labeling operations.
We have reviewed your response dated
February 20, 2019, which
states that you will establish and implement written procedures for packaging and labeling operations, and establish written control of use of labels, and written procedures to perform a reconciliation of any issuance and use discrepancies.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established written procedures for packaging and labeling operations.
You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints in accordance with 21 CFR 111.560.  Specifically, you have no written procedures for reviewing and investigating product complaints.  Once you have established such written procedures, you must also make and keep records of your compliance with such requirements for product complaints, in accordance with 21 CFR 111.570(b).
We have reviewed your response dated
February 20, 2019, which
states that you will establish written procedures to meet the requirements to review and investigate a product complaint, and that you will make and keep written complaint records for
(b)(4)
after the distribution of the product.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established a written complaint procedure.
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 written procedures for holding and distributing operations.
We have reviewed your response dated
February 20, 2019, which
states that you will establish and implement written procedures to periodically verify components are warehoused in a manner to prolong identity, purity, strength, and composition by properly maintaining temperature, humidity, and light.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established a written procedure for holding and distribution.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products.  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 your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.  If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
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 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, FDA may assess fees to cover any reinspection related
costs from the responsible party for the domestic facility.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087.  You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D
Denver District Director
Program Division Director
Office of Human and Animal Foods
Division IV West
Content current as of:
08/06/2019
Regulated Product(s)
Dietary Supplements