Inspections, Compliance, Enforcement, and Criminal Investigations
United Nutrition Labs, Inc. 7/24/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
July 24, 2012
RETURN RECEIPT REQUESTED
Clifford S. Kerstetter, Jr
United Nutrition Labs, Inc.
5135 Old US Highway 322
Reedsville, PA 17084
Dear Mr. Kerstetter:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 5135 Old US Highway 322, Reedsville, PA between December 5 and 8, 2011 and on December 19, 2011 and January 11, 2012. The inspection revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR part 111). These violations cause the dietary supplement products manufactured at your facility, including your (b)(4) capsules, (b)(4) Tablets, (b)(4) Capsules, (b)(4) Capsules, (b)(4) powder, and (b)(4) 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 regulations for dietary supplements. You may find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov.
Our inspection of your facility revealed the following violations of the dietary supplement CGMP regulation (21 CFR Part 111). We have reviewed your response to the FDA Form 483, dated January 9, 2012, and found it to be inadequate for the reasons set forth below:
1. Your firm failed to establish product specifications for the identity, purity, strength, and composition of each batch of finished dietary supplements, as required by 21 CFR 111.70(e). Specifically, you failed to establish the required specifications for your (b)(4) Tablets product because you have not established specifications for the concentration of barley in this product.
We have reviewed your response, dated January 9, 2012, and found it to be inadequate. Your response states that you will implement new Standard Operating Procedures (SOPs) for each finished product to ensure that the finished product specifications are met. However, this response is inadequate because you did not provide any documentation with your response that would assist us in determining whether you have taken this corrective action.
2. Your firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, before being used as a dietary ingredient, as required by 21 CFR 111.75(a). Specifically, you did not perform identity testing on all the dietary ingredients listed on the label of your (b)(4) product, such as (b)(4) and (b)(4).
We have reviewed your response, dated January 9, 2012, and found it to be inadequate. Your response states that you will implement new SOPs for each finished product manufactured domestically to ensure that the finished product specifications are met. However, your failure to provide any documentation makes it impossible for us to evaluate whether you have taken this corrective action.
3. Your firm failed to include in your Master Manufacturing Record (MMR) for your (b)(4) Capsules Lot # (b)(4), (b)(4) Tablets-Lot # (b)(4), (b)(4) Capsules-Lot # (b)(4), and (b)(4) Capsules-Lot # (b)(4) procedures for sampling or a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2).
In your January 9, 2012 response, you stated that you will change your MMR to include procedures for sampling and a cross-reference to procedures for tests or examinations. This response, however, is inadequate; you failed to provide any documentation of changes to your MMR.
4. Your firm failed to calibrate instruments or controls used in manufacturing or testing a component or dietary supplement at the frequency specified in writing by the manufacturer or at routine intervals or as necessary to ensure the accuracy and precision of the instruments, as required by 21 CFR 111.27(b)(2)-(3). Specifically, your firm failed to calibrate the (b)(4) Infrared Spectroscopy ((b)(4)) used in the finished product release testing for a number of products. These products included (b)(4) Capsules, lot # (b)(4); (b)(4) powder, lot # (b)(4) and (b)(4) Tablets, lot # (b)(4).
Your response dated January 9, 2012 stated that you will implement an SOP to ensure all equipment is calibrated at the appropriate interval. This corrective action will be verified during the next inspection. Your response also stated that the (b)(4) was calibrated as of 12/14/2011 and that all testing will restart with the newly calibrated (b)(4). This response, however, is inadequate, as you failed to provide any documentation of these changes.
The above violations are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your dietary supplement products are in compliance with the laws and regulations enforced by FDA, including the CGMP regulations for dietary supplements (21 CFR Part 111 ).
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
In addition to the above violations, we have the following comment. Under 21 CFR 111.12(c), each person engaged in the manufacturing, packaging, labeling, or holding or in performing any quality control operations must have the education, training, or experience to perform the person's assigned functions. However, we note that your firm's Quality Control Director is not qualified to perform her assigned functions in that she does not have the experience, knowledge, and level of training necessary to perform the functions of this position.
Your firm has had three Quality Control Directors since our October 2010 inspection, none of whom have been qualified to hold this position. During our Regulatory Meeting on February 17, 2011, you committed to hiring a qualified individual to head your Quality Unit and we explained to you what types of professional qualifications would be appropriate for this position. In your response dated January 9, 2012, you stated that you have plans to improve the training and experience of your personnel. Specifically, you stated that your Quality Control Director and Accounts Executive will complete additional educational courses in quality control in order to gain experience and training. You also stated that you will also be receiving training from the NFR DBA over the next year and DSQP training for Dietary Supplement Quality Professional Training, and that your personnel in a quality control capacity on the production floor have received training through Compliancewire from Kaplan EduNeering on CGMP requirements for quality control. We will re-evaluate the qualifications of your Quality Control Director during the next inspection.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations described above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show corrections. If you cannot complete all corrections within fifteen (15) days, please state the reason for the delay and the time within which the corrections will be completed.
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.
Your written response should be sent to Kristina Donohue, Compliance Officer, at the address noted above. If you have any questions with regard to this letter, Kristina Donohue can be reached at 215-717-3078 or Kristina.Donohue@fda.hhs.gov.
Kirk D. Sooter
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director