- Pacific Nutritional Inc
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Seattle District|
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
April 15, 2016
VIA CERTIFIED MAIL
In reply refer to Warning Letter SEA 16-10
Michael E. Schaeffer, President and CEO
Pacific Nutritionals, Inc.
P.O. Box 820829
Vancouver, WA 98682
Dear Mr. Schaeffer:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 6317 NE 131st Avenue, Suite 103, Vancouver, Washington, on November 9 through 23, 2015. We collected product labels during the inspection for products you manufacture, including “(b)(4),” “(b)(4) Multivitamin,” “Ashwagandha,” and (b)(4).” Based on the inspection and a review of your product labeling, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
We have received your written response to the Form FDA 483, Inspectional Observations, via email on December 15, 2015, and by letter on December 21, 2015, which was issued to you on November 23, 2015. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
Unapproved New Drugs
The FDA reviewed the product label for the (b)(4) “(b)(4) product. The claims on this product label establish that the product is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
An example of some of the claims on this product label that provide evidence that this product is intended for use as a drug include:
- “Advanced Pain Relief”
(b)(4) “(b)(4)” product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Adulterated Dietary Supplements
Even if (b)(4) “(b)(4)” product did not have therapeutic claims which makes it an unapproved new drug, the product would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the product has been prepared, packed, or held under conditions that do not meet the current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). Further, the “(b)(4)',” “Ashwagandha,” “(b)(4),” and “(b)(4) Multivitamin” products that you contract manufacture are also adulterated within the meaning of section 402(g)(1) [21 U.S.C. § 342(g)(1)] of the Act for the reasons described above.
During the November 9 through 23, 2015, inspection, our FDA investigator observed the following serious violations of the CGMP regulations for dietary supplements:
1. You failed to establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1). Specifically, after review of your batch production records for “Ashwagandha,” which also double as master manufacturing records, the following deficiencies were noted: “Ashwagandha,” lot number (b)(4) did not have in-process specifications regarding the blending operations utilized during manufacturing.
Once you have established in-process specifications, you must determine whether the above specifications have been met, as required by 21 CFR 111.73. In addition, you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
We have reviewed your response correspondence dated December 15, 2015. The adequacy of your response cannot be evaluated because of the lack of supporting evidence regarding the in-process controls utilized for your “Ashwagandha” product.
2. You failed to establish 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). Specifically, you failed to establish finished product specifications for the “'(b)(4),” “Ashwagandha,” (b)(4),” “(b)(4) Multivitamin,” and “(b)(4) dietary supplements as evidenced by your batch production records and Pacific Nutritionals, Inc. (PNI) Certificates of Analysis.
Once you have established finished product specifications, you must verify that the specifications are met, as required by 21 CFR 111.75(c), and 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). In addition, you must make and keep records in accordance with 21 CFR 111.95(b).
We have reviewed your response correspondence dated December 15, 2015. Your response included copies of revised product specifications for the “(b)(4)” and “(b)(4) Multivitamin” which only included microbial specifications at the finished product stage. Your finished product specifications for “(b)(4)” and “(b)(4) Multivitamin” are inadequate because you have not demonstrated that you have established specifications for identity, purity, strength, and composition of these products at the finished product stage, as required by 21 CFR 111.70(e).
Additionally, you did not include any finished product specifications for your “Ashwagandha,” “(b)(4),” and “(b)(4)” products for our review. Product specifications for these products will need to be provided for us to fully evaluate the adequacy of the response.
3. Your quality control failed to approve, or reject all processes, specifications, written procedures, controls, tests, 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, our investigator observed that system suitability for your HPLC equipment was not performed per your approved procedure, SOP QC 703 “(b)(4) System Suitability.” The system suitability for the HPLC testing was performed via an alternate procedure which had not been approved for use by quality control personnel. For example, our investigator observed that your approved SOP QC 703 specified different detector wavelengths, mobile phases, and columns than were actually used by following the alternative procedure.
We have reviewed your response correspondence dated December 15, 2015. You stated that you have revised SOP QC 703 “(b)(4) System Suitability,” and you provided a revised copy to demonstrate the procedure that the investigator observed in use is now approved by the Quality Control Manager. We acknowledge that you have also revised SOP 5.1-001 “SOP & Forms: Writing, Reviewing, Approval, Revision and Auditing,” and that you have provided a copy to demonstrate that it now requires updating Laboratory/QC SOPs before implementing process changes authorized by Quality Management. However, system suitability is method specific and verifies the sensitivity, reproducibility, and the ability of the method to resolve a peak or peaks of interest based on specific chromatographic parameters. We are therefore unable to evaluate the adequacy of your proposed corrective actions because you have not provided the following documentation for SOP QC 702 HPLC Analysis of Water Soluble Vitamins and SOP QC 709 HPLC Analysis of (b)(4):
• Specifics for the method
• Peak Resolution for the analyte(s) of interest
• Peak Symmetry for the analyte(s) of interest
• Reproducibility data based on replicate injections of a standard (% agreement specification included)
• Sample analysis data
4. You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d). Specifically, our investigator observed the (b)(4) Spectroscopy ((b)(4)) testing utilized by your firm to release incoming dietary components, which are further used in the manufacturing of dietary supplement products. However, you were unable to demonstrate that the non-compendia standards originating from previous material lots were thoroughly characterized to ensure their identity, purity, quality, and strength. Non-compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength. Once characterized, the official qualification documentation of these standards must be reviewed and approved by Quality Control prior to use.
5. You failed to calibrate instruments or controls used in manufacturing or testing a component or dietary supplement to ensure the accuracy and precision of the instruments or controls as required by 21 CFR 111.27(b). Specifically, the scales used by your firm to weigh dietary components are not adequately calibrated to demonstrate measurements are accurate within the full range of use during manufacturing. For example, your (b)(4), model number (b)(4), serial number (b)(4), and (b)(4), model number (b)(4), serial number (b)(4) scales were (b)(4) calibrated using (b)(4) pounds (lbs.) reference weights and verified (b)(4) with weight checks using (b)(4) kg reference weights. These scales were used to weigh components used in the manufacturing of dietary supplement products, including (b)(4),” lot number (b)(4), which consisted of the component Thyme (b)(4)) with a weight of 0.0(b)(4) kg, and “(b)(4) Multivitamin,” lot number (b)(4), which consisted of the component Manganese (b)(4) with a weight of 0.0''' kg. Calibrations of your scales to ensure accuracy and precision across the operating range of the instrument were inadequate because the calibration points did not include weight verification below 25 lbs. (11.34 kg) in order to encompass the lower weight measurements.
We have reviewed your response correspondence, dated December 15, 2015, and determined it to be inadequate in that you failed to calibrate the (b)(4); Serial #(b)(4) scale used in the manufacturing or testing of a component or dietary supplement to ensure the accuracy and precision of the instruments at levels of its intended use, as required by 21 CFR 111.27(b). During the inspection it was noted that you are weighing components used in the manufacture of dietary supplements below 0.05 kg; for example, the batch record for “(b)(4),” lot number (b)(4), shows the ingredient Thyme (b)(4) was added at a weight of 0.0(b)(4) kg. Calibrating at 0.05 kg will not provide you the accuracy and precision of the balance for use at weights below 0.05 kg. As part of your response, you provided a calibration document for the (b)(4); Serial #(b)(4) with a maximum weight capacity of (b)(4) lbs. ((b)(4) kg). During the review of your calibration data it was observed that you did not calibrate for those weights of measure below 50 g (0.125 lbs./0.05 kg) to demonstrate this scale’s accuracy and precision below 50 g.
Misbranded Dietary Supplements
Even if your “(b)(4)” product were not an unapproved new drug, it would still be a misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343], as are your “(b)(4) Multivitamin,” “(b)(4),” and “Ashwagandha” products, based on violations of the labeling requirements for dietary supplements, which are found in 21 CFR Part 101. Your labeling violations include the following:
6. Your “(b)(4) Multivitamin” product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number.
7. Your “(b)(4) Multivitamin” product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product using the term “dietary supplement” as required by 21 CFR 101.3(g). Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product.
8. Your “(b)(4) Multivitamin” and “(b)(4)” 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. The terms "serving" or "serving size" for a dietary supplement are defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example,
- The directions for use on your “(b)(4) Multivitamin” product label suggest the consumer “Take one capsule twice daily with food,” but the serving size lists “2 capsules.” The serving size listed should be one capsule.
- The directions for use on your “(b)(4)” product label suggest children 9 to 12 take 2 capsules, but the serving size lists 1 capsule. The serving size should be 2 capsules.
- The directions for use on your “(b)(4)” product label suggest children 9 to 12 take 10 drops, but the serving size lists 5 drops. The serving size should be 10 drops.
9. Your “(b)(4) Multivitamin” and “(b)(4)” products are misbranded within the meaning of section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36. For example,
- Your “(b)(4) Multivitamin” product label declares the dietary ingredient “PABA,” but this is not the common or usual name for the dietary ingredient.
- Your “(b)(4)” product label declares the ingredient “vegetable fiber” in the ingredient statement but does not state the specific vegetable fiber(s).
10. Your “Ashwagandha” product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the FD&C Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction.
In addition to the violations cited above, we have the following comments:
- Your “Ashwagandha” product label includes the dietary ingredient withanolides which is misspelled as “(b)(4).”
- Your “(b)(4),” and “Ashwagandha” product labels bear the statement “percent Daily Values are based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
Section 743 of the FD&C 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. 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to Maria Kelly-Doggett, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about the contents of this letter, please contact: Seattle District Compliance Officer Maria Kelly-Doggett at (425) 302-0427.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560