Inspections, Compliance, Enforcement, and Criminal Investigations
Wyldewood Cellars Inc 6/23/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
June 23, 2014
Dr. John A. Brewer, Owner
Wyldewood Cellars Inc.
951 E. 119th Street
Peck, KS 67120
Dear Dr. Brewer:
An inspection of your dietary supplement manufacturing and juice processing facility, Wyldewood Cellars Inc., located at 951 E. 1191 Street in Peck, KS, was conducted October 21- November 26, 2013 by a representative of the Food and Drug Administration (FDA). During this inspection, our investigator observed significant deviations from current good manufacturing practice (CGMP) regulations for dietary supplements, which are set out under Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause dietary supplements 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 U.S.C.§ 342(g)(1)) in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
You can find the Act and FDA's regulations (including the dietary supplement CGMP regulations and the juice HACCP regulation) through links on FDA's internet homepage at http://www.fda.gov.
Adulterated Dietary Supplements
1. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a). Our investigator found that you did not prepare an MMR for any of your Elderberry Concentrate Dietary Supplement products.
We have reviewed your December 18, 2013 response. Although your response stated that you maintain MMRs as bottling records, your response is inadequate because it does not provide any MMRs for the products you manufactured for our review.
2. Your batch production record (BPR) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. Specifically, the BPR for your Elderberry Concentrate Dietary Supplement (batch no. 1149313) product only documented the date of the bottling and the number of bottles and cases manufactured. It did not comply with the following specific requirements in 21 CFR 111.260:
• Your BPR did not include the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
• Your BPR did not include 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)];
• Your BPR did not include the unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)];
• Your BPR did not include the identity and weight or measure of each component used [21 CFR 111.260(e)];
• Your BPR did not include 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)];
• Your BPR did not include the actual results obtained during any monitoring operation [21 CFR 111.260(g)];
• Your BPR did not include the results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
• Your BPR did not include documentation that the finished dietary supplement meets specifications established in accordance with §111.70(e) and (g) [21 CFR 111.260(i)];
• Your BPR did not include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)).
• Your BPR did not include documentation, at the time of performance,of packaging and labeling operations, including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference tothephysical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)].
• Your BPR did not include documentation, at the time of performance, that quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(1)].
We have reviewed your December 18, 2013 response. However, your response is inadequate because it does not provide any BPRs for the products you manufactured for our review.
3. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you stated to our investigator that you do not collect and hold reserve samples because they have a shelf life of two years.
We have reviewed your December 18, 2013 response. Your response indicated you collected reserve samples from all production runs past October 21, 2013. We will verify the adequacy of this correction during any future inspection.
4. You failed to establish the following specifications required by 21 CFR 111.70:
• An identity specification for each component that you use in the manufacture of a dietary supplement [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 dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)];
• Limits, for each component that you use in the manufacture of a dietary supplement, on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplements to ensure quality of the dietary supplements [21 CFR 111.70(b)(3)];
• Label and packaging specifications for your dietary supplement [21 CFR 111.70(d)];
• Product specifications 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 [21 CFR 111.70(e)];
• Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
We have reviewed your December 18, 2013 response. However, your response is inadequate because it does not address any of these specifications or provide documentation in support of establishing them.
5. You failed to make and keep adequate documentation of any calibration of instruments you use in manufacturing your dietary supplements, as required by 21 CFR 111.35(b)(3). The Agency's inspection of your facility revealed that you do not have calibration records for your temperature measuring devices (e.g., thermometers, infrared thermometer gun) or other instruments used in the production of your dietary supplements. Among other requirements, your documentation must identify the instrument or control calibrated; provide the date of calibration; identify the reference standard used; identify the calibration method used, including appropriate limits for accuracy and precision; and provide the calibration reading or readings found [21 CFR 111.35(b)(3)(i)-(v)].
We have reviewed your December 18, 2013 response. Your response is in adequate because you did not provide documentation in support of meeting this requirement for our review. Although you stated that "(b)(4) will be installed within (b)(4) to provide real time written documentation of the pasteurization temperature," written documentation must include all of the information set forth in 21 CFR 111.35(b)(3). The adequacy of any correction will be verified during any future inspection.
6. Your firm failed to establish written procedures to fulfill the requirements for reviewing and investigating product complaints as required by 21 CFR 111.553 and 111.560. Specifically, your product complaint procedures did not specify that a qualified person review and investigate any product compliant that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirement of 21 CFR Part 111 (see 21 CFR 111.560(a)). Your procedures also failed to specify that quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed (see 21 CFR 111.560(b)), and that the review and investigation of the product complaint must extend to all relevant batches and records (see 21 CFR 111.560(c).)
We have reviewed your December 18, 2013 response, including your SOP 008 entitled "Standard Operating Procedure - Consumer Complaints and/or Returns. "Your SOP 008 explains that a "consumer complaint or return log is maintained at each retail location and in the wholesale sales area." However, you must establish and maintain your own written procedures to ensure that product complaints are reviewed and investigated pursuant to the requirements set forth in 21 CFR 111.560.
7. You failed to establish and follow written procedures for handling returned dietary supplements in accordance with the requirements of 21 CFR 111 subpart N. Specifically, your written procedures do not address that you must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and makes a deposition decision (see 21 CFR 111.510); when a returned dietary supplement may be salvaged (see 21 CFR 111.520), or when a returned dietary supplement must be destroyed or otherwise suitably disposed of (see 21 CFR 111.515).
We have reviewed your December 18, 2013 response, including your SOP 008 entitled "Standard Operating Procedure - Consumer Complaints and/or Returns. "Your response is inadequate because your SOP 008 does not include any written procedures addressing the requirements set forth in 21 CFR 111.510, 111.515, and 111.520.
8. Your staff failed to use hygienic practices necessary to protect against contamination of components, dietary supplements, or contact surfaces in accordance with the requirements of 21 CFR 111.10(b). Specifically, our investigator observed the following:
• Your production staff employee did not wash his hands thoroughly (and sanitize them if necessary to protect against contamination with microorganisms) after times when his hands may have become soiled or contaminated (21 CFR 111.10(b)(3)(ii)). Specifically, our investigator observed your employee leave the facility to dump a trash can and then return and proceed to assist in scooping the Elderberry Concentrate from a receiving drum into a mixing tank by placing his hands within the scoops and in contact with the concentrate.
• Your employees failed to wear hair nets or other effective hair restraints in an effective manner to protect against the contamination of component, dietary supplement, or contact surfaces as required by 21 CFR 111.10(b)(6). Specifically,our investigator observed that two of the (b)(4) production staff did not wear hair nets on their heads during the equipment setup and dietary supplement production.
• You failed to ensure that your employees do not eat food and drink beverages while working in an area where components, dietary supplements, or any contact surfaces are exposed (21 CFR 111.10(b)(8)). Specifically, our investigator observed your production staff drinking from open top cups during equipment setup and production. Our investigator also observed these cups sitting on production room equipment such as table tops and the filling machine.
We have reviewed your December 18, 2013 response, including your SOP 002 entitled "Standard Operating Procedure - Control of Employee Health Conditions. "Your response indicated that all employees have been retrained and agree to adhere to the SOP. We will verify the adequacy of this correction during any future inspection.
9. 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, as required by 21 CFR 111.103. Specifically, during our inspection you stated that you have not established written procedures for quality control operations.
We have reviewed your December 18, 2013 response. Your response is inadequate because it does not provide any written procedures for quality control operations.
This letter is not intended as an all-inclusive list of the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the dietary supplements CGMP regulations and the juice HACCP regulation. You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in legal action without further notice. These actions include, but are not limited to, seizure and injunction.
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting there-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should respond 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 noted above. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If corrective action cannot be completed within fifteen(15) days, you should explain the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be sent to Compliance Officer Matthew R. Sleeter, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact, Mr. Sleeter at 913-495-5151.
Cheryl A. Bigham
Kansas City District