WARNING LETTER
Waiakea Bottling Inc.
MARCS-CMS 681285 —
August 13, 2024
Delivery Method:
Electronic Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ryan Emmons
Recipient Title
CEO
Waiakea Bottling Inc.
4800 Hannum Ave #135
Culver City
,
CA
90230
United States
ryanemmons@waiakea.com
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
August 13, 2024
WL 681285
Dear Mr. Emmons:
The United States Food and Drug Administration (FDA) inspected your bottled water manufacturing facility located at 447 Kalanianaole Avenue, Hilo, HI 96720-4772 from December 19, 2023 through February 14, 2024. Our inspection revealed significant violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations, Part 129 (21 CFR Part 129) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). These violations render the bottled water products processed at your facility adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).You may find the Act and FDA’s regulations through links on FDA’s Internet homepage at www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued a Form FDA 483 (FDA-483), Inspectional Observations. We received responses to the FDA-483 on March 14, 2024 and March 29, 2024. Upon request, you provided a revised Food Safety Plan on April 3, 2024. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your responses below.
Processing and Bottling of Bottled Drinking Water Regulations (21 CFR 129):
1. Your treatment of product water was not done in a manner that was effective in accomplishing the intended purpose, as required by 21 CFR 129.80(a). Specifically, your facility uses
(b)(4)
to treat product water to remove any biological hazards as the final treatment step prior to filling. Your specification sheet for the
(b)(4)
indicates that a typical
(b)(4)
for clean water at ambient temperatures for
(b)(4)
would be
(b)(4)
. However, your “
(b)(4)
water treatment reading
(b)(4)
” records dated
(b)(4)
, indicated that there were
(b)(4)
. A
(b)(4)
indicates that the performance of
(b)(4)
is ineffective, and therefore not achieving the intended purpose. Also, your “
(b)(4)
Water Treatment Reading” records dated
(b)(4)
showed that your
(b)(4)
ranged from
(b)(4)
to
(b)(4)
, which is far above the maximum
(b)(4)
listed by the
(b)(4)
manufacturer. This further indicates the
(b)(4)
treatment was not being done in a manner that was effective in accomplishing the intended purpose.
Your firm started receiving consumer complaints regarding foreign material including but not limited to apparent “mold”, “white blob”, and “floaters” in 1-liter bottles of your Waiakea Hawaiian Volcanic Water, lots WB123275 and WB123276, which were bottled and processed on
(b)(4)
. You sent Waiakea Hawaiian Volcanic Water, lot WB123275, for third-party laboratory analysis, which found heterotrophic plate count (HPC) at >5700 CFU/mL, Pseudomonas aruginosa at >2400 MPN/100mL, and mold at 15 CFU/mL. A second analysis of lot WB123275, conducted on December 27, 2023, identified Paecilomyces lilacinus. Additionally, your Quality Control department found elevated levels of Pseudomonas from in-house testing of lot WB123276, and you eventually destroyed
(b)(4)
cases from the lot. FDA laboratory analysis of sample #1227389, consisting of six unopened individual 1-liter bottles of Waiakea Hawaiian Volcanic Water, lot WB123275, found yeast and mold counts (YMC/mL) up to 16,000, with the following species identified: Mycosphaerella heimii, Penicillium corylophilum, Remotididymella destructive, Aspergillus versicolor, Dioszegia species, Cladosporium halotolerans, Penicillium simplicissimum, Cladosporium halotolerans, and Pyrenochaetopisis indica. The findings of Pseudomonas aeruginosa, Paecilomyces lilacinus, and other fungal species demonstrates that your
(b)(4)
step was not done in a manner that is effective in accomplishing the intended purpose, as required by 21 CFR 129.80(a).
In your March 29, 2024, response, you stated that at the time the
(b)(4)
was measured, “
(b)(4)
was in ‘
(b)(4)
mode’”, and “[i]n the correct mode, there would not be a
(b)(4)
variation.” We cannot fully evaluate this response because you did not provide for our review any documentation to evaluate this corrective action. We remain concerned that the
(b)(4)
for the treatment of product water is not operated in a manner that is effective in accomplishing the intended purpose.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C of 21 CFR 117):
2. Your process controls did not include, as appropriate to the nature of the applicable control and its role in the facility's food safety system, parameters associated with the control of a hazard, as required by 21 CFR 117.135(c)(1)(i). Specifically, your hazard analysis identifies pathogenic bacteria, HPC/P, Aeruginosa, Fungus (Yeasts & Molds), and viruses as a hazard requiring a preventive control at the “
(b)(4)
Disinfection of Product Water”
(b)(4)
step. However, your process control at the
(b)(4)
step identifies the critical limit of the
(b)(4)
as “must be in the ‘
(b)(4)
’ operational range which assures adequate
(b)(4)
is
(b)(4)
to effect
(b)(4)
reduction”. This is an inappropriate process control because it does not include parameters (i.e., critical limits) to ensure control of the hazard, such as Power,
(b)(4)
, and
(b)(4)
, as recommended in Section 9.2.2 of the User Manual for the
(b)(4)
.
Your response received on March 29, 2024, states that you have implemented a verification process to test the
(b)(4)
at start-up, added an additional sanitizing step, and added
(b)(4)
calibration of
(b)(4)
and
(b)(4)
monitors. These corrections do not address the inadequate critical limits and monitoring procedures detailed above. Furthermore, a review of the revised Food Safety Plan provided on April 3, 2024, does not appear to reflect these additional activities.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or
(b)(3)(A)
if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
We believe a meeting with us to discuss the violations and corrective actions would be beneficial to your firm and the FDA. During that meeting, you will have an opportunity to discuss and ask any questions you may have regarding the requirements of the CGMP & PC rule, 21 CFR 117, and the Bottled Drinking Water regulations, 21 CFR 129.
We request that you contact Elodie X. Tong-Lin, Compliance Officer at 510-337-6870 or at Elodie.Tong-Lin@fda.hhs.gov within five (5) business days of receipt of this letter to schedule a regulatory meeting.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Pkwy
Alameda, CA 94502
Refer to Unique Identification Number
681285
when replying.
If you would prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification Number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov or 510-337-6870.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
cc:
Mr. Kyle D. Lemmer, Vice President of Operations
447 Kalanianaole Avenue
Hilo, HI 96720-4772
klemmer@waiakea.com
Content current as of:
09/03/2024
Regulated Product(s)
Food & Beverages