- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Andrew Foti
- BMF, Inc.
Road # 798, Km. 0.6 Bo. Rio Cañas
Caguas, PR 00726
- Issuing Office:
- Office of Human and Animal Food Operations East Division IV
September 18, 2019
19-HAFE4-WL-09/CMS No. 584111
Dear Mr. Foti:
The U.S. Food and Drug Administration (FDA) inspected your bottled water manufacturing facility located at Road # 798, Km. 0.6, Bo. Rio Cañas, Caguas, PR 00726, from March 29 to April 17, 2019. Our inspection revealed serious violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129. 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. We also reviewed your labeling and found serious violations of 21 CFR 101 which render the bottled water products misbranded within the meaning of section 403 of the Act, 21 U.S.C. §343. You may find the Act and FDA’s regulations through links on FDA’s Internet homepage at .
Our investigators issued the Form FDA-483, Inspectional Observations, at the conclusion of the inspection. We acknowledge receipt of your firm’s written response received on May 22, 2019 to the FDA-483, and we address this response below.
The following significant violations of the CGMP regulation for bottled water were observed during the inspection:
1. You failed to conduct follow-up testing to determine whether any of the coliform organisms were Escherichia coli, after coliform organisms were detected in your product and operations source water, as required by 21 CFR 129.35(a)(3)(i).Specifically, your firm uses water from a source other than the public water system (Well (b)(4)) for the processing and bottling of drinking water. On March 25, 2019, a sample from Well (b)(4) found a total coliform result of (b)(4) MPN/(b)(4) mL.
Additional sample from Well (b)(4) on March 8, 2019 had a total coliform result of (b)(4) MPN/(b)(4) mL. However, your firm did not conduct the required follow-up testing to determine whether any of the isolated coliform organisms were Escherichia coli. In addition, from February 11 through March 22, 2019, your firm failed to collect and analyze water from Well (b)(4) for total coliforms. Water obtained from sources other than a public water system must be sampled and analyzed for total coliforms at least once each week.
Your response to FDA-483, received on March 22, 2019, stated deviations from testing were addressed and properly corrected. However, we cannot evaluate your response because it failed to include information addressing what steps were taken to identify the root cause of high coliform counts of weekly water source samples and your corrective actions implemented to prevent recurrence.
2. Your firm failed to take and analyze representative samples of bottled drinking water for (b)(4) testing at least (b)(4) a week for each type of bottled drinking water produced during a day's production run, as required by 21 CFR 129.80(g)(1). Specifically, you did not take and analyze samples of your finished bottled water produced from (b)(4) and from (b)(4). Additionally, representative samples for each type of bottled water produced were not collected on a (b)(4) basis for (b)(4) testing on (b)(4) occasions. For example, representative samples were not collected for the following dates: (b)(4) and (b)(4).
Your response to FDA-483 stated samples from the (b)(4) production lines will be collected from now on. We will verify your proposed corrective action during the next scheduled inspection.
In addition, your products are misbranded as follows:
1. Your pure H2O, Pure Baby, and gotiTas products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false and misleading. The product labels state that the product is Distilled Drinking Water. However, on March 29, 2019, our investigator observed that your distiller was not operable. You were unable to determine when the distiller went out of operation. On March 29, 2019, you bottled pure H2O with labels that falsely stated that the product was distilled. All products labeled and distributed as distilled while the distiller was inoperable are similarly false and misleading within the meaning of section 403(a)(1) of the Act. Your Pure Baby product is further misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the Nutrition Facts label declares 4 grams of protein when no protein was added to the product.
We acknowledge receipt of your May 3, 2019, written response wherein you state that you have been using an (b)(4) process for your water. You state that this (b)(4) provides water with a “distilled water (b)(4).” 21 CFR 165.100(a)(2)(iv) requires that “distilled water” be produced by distillation. Unless the water is produced by distillation, it cannot be called “Distilled Water.”
2. Your Mapfre and Transcita products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the products do not have an appropriate statement of identity in accordance with 21 CFR 101.3 because “Mapfre” and “Transcita” are not appropriate common or usual names for a bottled water product.
3. Your gotiTas, Pure Baby, and pure H2O products are misbranded within meaning of section 403(g) of the Act [21 U.S.C. § 343(g)]. The products appear to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the Act and the food does not appear to conform to such definition and standard in accordance with 21 CFR 165.110. Specifically,
a. The gotiTas product is labeled for use in infant formula and the Pure Baby product has a vignette showing a baby which implies its use for infants. 21 CFR 165.110(a)(3)(iii) states that, when the label or labeling of a bottled water product states or implies that the bottled water is for use in feeding infants, and the product is not commercially sterile under 21 CFR 113.3(e)(3)(i), the product label shall bear conspicuously and on the principal display panel the statement “Not sterile. Use as directed by physician or by labeling directions for use of infant formula.” Your gotiTas product is labeled as “(b)(4)” but does not include the rest of the required statement. Your Pure Baby product does not include any of the required statement.
b. The pure H2O product in this violation was not produced by distillation and does not meet the requirement for distilled water in 21 CFR 165.110(a)(2)(iv).
4. Your gotiTas, pure H2O, and Pure Baby product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear a nutrient content claim, but the products do not meet the requirements to make such a claim.
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
In accordance with 21 CFR 101.61(a), a claim about the level of sodium or salt in a food may only be made on the label or labeling of a food if, among other requirements, the claim uses one of the terms defined in 21 CFR 101.61(b)(1)(iii) in accordance with the definition for that term. Under 21 CFR 101.61(b)(1)(iii), the term “sodium free” may be used on a label of a food if (i) the food contains less than 5 milligrams of sodium per reference amount customarily consumed and per labeled serving, (ii) the food contains no ingredient that is sodium chloride and (iii) the food meets these requirements without benefit of special processing, alteration, formulation, or reformulation to lower the sodium content and is labeled to disclose that sodium is not usually present in the food. However, the products do not meet the criteria under 21 CFR 101.61(b)(1)(iii) because the labels bear the claim ‘Sodium Free’ but the labels fail to disclose that sodium is not usually present in the food, such as ‘water, a sodium free food.” Therefore, your gotiTas, pure H2O, and Pure Baby products are misbranded within the meaning of section 403(r)(1)(A) of the Act.
5. Your Transcita product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). For example, the Nutrition Facts label must be declared in both Spanish and English as required by 21 CFR 101.15(c)(2).
6. Your gotiTas, Pure Baby, Mapfre, and Transcita products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5. Specifically, the gotiTas, Pure Baby, Mapfre, and Transcita product labels do not include the zip code for the manufacturer or distributor. The gotiTas product also fails to include a full street address and zip code as required by 21 CFR 101.5. However, the street address may be omitted if it is shown in a current city directory or telephone directory.
7. Your Mapfre product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of fluid measure, as required by 21 CFR 101.7.
The violations listed in this letter are not intended to be an all-inclusive list of violations. It is your responsibility to ensure your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by the FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
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.
We request that you notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps toward long term corrective actions. If the corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your response to the attention of: Mr. Ramon Hernandez, Program Division Director,466 Avenida Fernández Juncos, San Juan, Puerto Rico 00901-3223.
If you have any questions regarding this letter, please contact Ms. Pearl Lopina, Compliance Officer, at (407) 475-4730 or .
Ramon A. Hernandez
District Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food Operations
East Division IV