WARNING LETTER
Wellington Foods MARCS-CMS 505161 —
- Delivery Method:
- United Parcel Service
- Recipient:
-
Recipient NameMr. Anthony E. Harnack II
- Wellington Foods
1930 California Avenue
Corona, CA 92881
United States
- Issuing Office:
- Los Angeles District Office
United States
| |
Los Angeles District 19701 Fairchild Road Los Angeles, CA 92612 |
WARNING LETTER
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
January 6, 2017
WL # 11-17
Mr. Anthony E. Harnack II, President
Wellington Foods, Inc.
1930 California Avenue
Corona, CA 92881
Dear Mr. Harnack:
On April 26 through May 27, 2016, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 1930 California Avenue, Corona, California. During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the 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 requirements for dietary supplements.
Our investigators’ observations were noted on Form FDA-483, Inspectional Observations, which was issued to you on May 27, 2016. We also received written responses from your counsel, (b)(4), dated July 12, August 3 and October 12, 2016 and address these responses below.
You may find the Act and the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
1. You failed to ensure the water that may become a component of a finished batch of dietary supplement, at a minimum, complied with applicable Federal, State and local requirements, as required by 21 CFR 21 CFR 111.365(c).
Title 17, California Code of Regulations specifies that heterotrophic plate counts for potable water are to be no more than 500 cfu/ml. A review of your Microbial Evaluation of Water records from November 19, 2014 through April 28, 2016 found at least 68 instances where the heterotrophic plate counts in your treated water sampling points (b)(4), representative of water that is used as a component in all your liquid dietary supplement products, exceeded 500 cfu/ml. The inspection found you used this water in the manufacture of finished dietary supplement products. Specifically, since 11/19/14, weekly water samples from eighteen (18) sampling points for treated and untreated water located in the (b)(4) have produced 498 results that exceeded the Federal, State, and local standard for potable water heterotrophic plate count of 500>
Examples of these products include, but are not limited to the following products:
(b)(4)
We reviewed your response, dated July 12, 2016. We acknowledge your firm’s actions in sanitizing key components of the water system, sanitization and/or replacement of hoses to pipelines supplying municipal water, and an increased frequency of sanitization and an upcoming GMP audit of the firm by a third party. However, based on this information, we are unable to evaluate the adequacy of this corrective action to ensure going forward that water that may become a component of your finished batches of dietary supplements will, at a minimum, be in compliance with applicable Federal, State and local requirements. We intend to verify the adequacy of this correction at a future inspection.
2. Your quality control personnel did not reject a component and dietary supplement for which a specification was not met, as required by 21 CFR 111.77(a). Specifically,
- Your internal specifications for purified water used as a component in your finished dietary supplement products includes (b)(4) to be absent per 100ml. Your firm appeared to start testing for the presence of (b)(4) in your purified water in July 2015. A review of your Microbial Evaluation of Water records from July, 2015 through April 28, 2016 found 37 instances where (b)(4) was present in your treated water sampling points (b)(4), yet this component was not rejected.
- Your internal specifications for purified water used as a component in your finished dietary supplement products includes heterotrophic plate counts to be not more than (b)(4). A review of your Microbial Evaluation of Water records from November 19, 2014 through April 28, 2016 found 88 instances where the heterotrophic plate counts exceeded these specifications, yet this component was not rejected.
- Sodium copper chlorophyllin, to which you assigned lot number (b)(4), was found by in-house analysis on November 6, 2014 to have a total copper content of (b)(4)%. Confirmative analysis by an outside laboratory found total copper content to be (b)(4)%. Your specification for sodium copper chlorophyllin references total copper content to be not less than (b)(4)% and not more than (b)(4)%. The dietary ingredient was approved by your quality control personnel on November 11, 2014 without justification for the out-of-specification material and used in the manufacture of Product WF250680, liquid multivitamin supplement, lot 358-1-A5 on January 6, 2015 and lot 330-2-B5 on February 3, 2015.
3. 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. You also failed to implement quality control operations in your manufacturing, packaging, labeling, or holding operations for producing the dietary supplements to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing records as required by 21 CFR 111.65.
Specifically:
- Your firm’s quality control personnel failed to conduct a material review and make a disposition decision when an established specification under 21 CFR 111.70(b)(3) was not met [21 CFR 111.113(a)(1)]. For example,
- (b)(4) references Potassium of 220 mg/16 fl. oz. serving based on its labeling. (b)(4). Your internal testing found the potassium content for lot 295-3-C6 of this product to be (b)(4) mg/16 fl. oz. serving on March 15, 2016. Your quality control personnel approved this batch for release and distribution on March 18, 2016.
We reviewed your responses, dated July 12, 2016 and August 3, 2016. You reference the potencies in the Dietary Supplements Compendium (USP 2015) for potassium chloride and potassium sorbate. We find this information inadequate because the product was found sub-potent for potassium. Further, you did not identify which salt form nor have you adequately determined the root cause of the sub-potency. Additionally, you did not provide a copy of your specifications for the components, supplier COA’s stating the purity of the incoming component, nor have you provided test results verifying the potency and therefore we are unable to evaluate the adequacy of your response.
Further, you state a finished product specification of NLT (b)(4) of Potassium in the product. As noted above, it appears the specifications initially established were inadequate and the investigation conducted has not adequately determined the root cause of the sub-potency. You state the out-of-specification result of (b)(4)/serving was due to 5% method variability, which resulted in your subsequently changing the specification from (b)(4). However, we are unable to evaluate this result as you did not provide development data which supports the adequacy and variability of the method, and justifies widening the specification.
- (b)(4) has a zinc specification of 15 mg/per fluid ounce (30 ml) serving based on its labeling. Your batch production record allows for a (b)(4)% overage (b)(4), and shows an out-of-specifications finding of (b)(4) mg per 30 ml. Your firm opened an investigation for this out-of-specifications finding. Retesting of lot 330-2-B5 on February 18, 2015 found the initial lot’s zinc content to be (b)(4) mg/fluid ounce, and resampling disclosed zinc content to be (b)(4) mg/fluid ounce, (b)(4)mg/fluid ounce, and (b)(4) mg/fluid ounce in three resamples. Your quality control personnel approved this batch for release and distribution on February 24, 2015.
We reviewed your responses, dated July 12, 2016 and August 3, 2016. The out of specification investigation for lot 330-2-B5 of this product, to include justification for a disposition reason, has not been submitted for our review and therefore we are unable to evaluate the adequacy of your response. In addition, you reference a finished product specification of (b)(4) mg of Zinc in product. It appears the specifications initially established were inadequate, as the product continues to be out of the (b)(4) mg specification, and the investigation conducted has not adequately determined the root cause of the Zinc sub-potency. You state the out-of-specification result of (b)(4)/serving was due to 5% method variability, which resulted in you subsequently changing the specification from (b)(4) mg to a range of (b)(4). However, we are unable to evaluate this result as you did not provide development data which supports adequacy and variability of the method, and justifies widening the specification.
- Your quality control unit released for distribution dietary supplement products that were super-potent for dietary ingredients. The following are representative examples of finished products that were released and distributed with magnesium, potassium, vanadium, folic acid, L-carnitine, and selenium in excess of your specifications:
Product | Lot | Superpotent Ingredients | Label Claim (per serving) | Specification (per serving) | Results (per serving) | Date Quality Control Approved |
WF250680, liquid multivitamin (b)(4) | 330-2-B5 | magnesium | 40 mg | (b)(4) | (b)(4) | 02/24/15 |
potassium | 50 mg | (b)(4) | (b)(4) | |||
selenium | 70 mcg | (b)(4) | (b)(4) | |||
358-1-A5 | magnesium | 40 mg | (b)(4) | (b)(4) | 01/29/15 | |
potassium | 50 mg | (b)(4) | (b)(4) | |||
selenium | 70 mcg | (b)(4) | (b)(4) | |||
244-2-E5 | magnesium | 40 mg | (b)(4) | (b)(4) | 05/14/15 | |
potassium | 50 mg | (b)(4) | (b)(4) | |||
selenium | 70 mcg | (b)(4) | (b)(4) | |||
(b)(4) | 041-1-K5 | folic acid | 400 mcg | (b)(4) | (b)(4) | 12/03/15 |
magnesium | 40 mg | (b)(4) | (b)(4) | |||
potassium | 50 mg | (b)(4) | (b)(4) | |||
selenium | 70 mcg | (b)(4) | (b)(4) | |||
(b)(4) | 104-3-I5 | magnesium | 8 mg | (b)(4) | (b)(4) | 09/30/15 |
potassium | 70 mg | (b)(4) | (b)(4) | |||
Vanadium | 500 mcg | (b)(4) | (b)(4) | |||
Selenium | 50 mcg | (b)(4) | (b)(4) | |||
(b)(4) | 103-1-I5 | magnesium | 40 mg | (b)(4) | (b)(4) | 09/29/15 |
Potassium | 50 mg | (b)(4) | (b)(4) | |||
(b)(4) | 274-3-D6 | L-carnitine | 1250 mg | (b)(4) | (b)(4) | 04/15/16 |
(b)(4) | 276-1-C6 | magnesium | 115 mg | (b)(4) | (b)(4) | 04/08/16 |
(b)(4) (b)(4) | 203-4-F5 | Potassium | 15 mg | (b)(4) | (b)(4) | 06/25/15 |
Selenium | 35 mcg | (b)(4) | (b)(4) | |||
352-3-A6 | Potassium | 15 mg | (b)(4) | (b)(4) | 01/20/16 | |
Selenium | 35 mcg | (b)(4) | (b)(4) |
We reviewed your response, dated July 12, 2016. It appears the upper limit for several of the above referenced ingredients have been changed to percentages referenced as “reasonable” allowable analytical variabilities on the highest ingredient potency; however, no justification is offered to increase these upper limits. Further, several of the products referenced above exceed the new upper limits assigned to the respective product. Additionally, the information provided did not offer an explanation of super-potency for potassium for lots 330-2-B5, 358-1-A5 and 244-2-E5 of WF250680, liquid multivitamin (b)(4); for (b)(4), liquid multivitamin (b)(4); for lot (b)(4), liquid multivitamin (b)(4), and for lot (b)(4), liquid antioxidant (b)(4). Moreover, you did not provide development data which supports adequacy and variability (5%, 10%, 20%) of the method, or justifies widening the specification. For these reasons we are unable to evaluate the adequacy of your response.
This letter may not list all the violations at your facility or that exist in connection with your products or their labeling. You are responsible for ensuring that your products are in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, 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 the re-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.
Please notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to correct the violations described above and to prevent similar violations in the future. Your response should include documentation to show that correction has been achieved. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
Your firm’s response should be sent to:
Ms. Kelly Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the Unique Identification Number FEI # 3008177334 when replying. If you have any questions about the content of this letter please contact: Dr. William Vitale, Compliance Officer, at 949-608-2919.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Los Angeles District Director
Cc:
David M. Mazzara, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435