NatureMost of New England, Inc. 5/24/12
Department of Health and Human Services
Public Health Service
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 587-7556
CMS # 240654
VIA United Parcel Service
May 24, 2012
Mr. Robert J. Trigo
NatureMost of New England, Inc.
60 Trigo Dr.
Middletown, CT 06457
Dear Mr. Trigo:
On September 22, 2011 through October 12, 2011, the U.S. Food and Drug Administration (FDA) inspected your firm located at 60 Trigo Dr., Middletown, Connecticut. During the inspection, our investigators found a number of 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 111
). These violations cause your dietary supplement products, C-Complex 1150 mg, 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 products have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements in 21 CFR Part 111.
In addition, FDA reviewed the labeling for several of your products, including your Internet website at
. Based on our review of the labeling for your Age-Less Skin Lotion and Poison Ivy Lotion products, we have determined that these products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) and (C) of the Act [21 U.S.C. § 321(g)(1)(B)(C)]. The claims made in the labeling for these products establish that your products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or to affect the structure or any function of the human body. The marketing of your products with these claims violates the Act. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at http://www.fda.gov.
Your significant violations are as follows:
Adulterated Dietary Supplements
Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is dietary ingredient prior to using the component in the manufacture of your dietary supplements, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm did not conduct an identification test or examination for dietary ingredients, including ascorbic acid, prior to using such ingredients in the manufacture
of your dietary supplement product C-Complex (1150 mg tablets, Batch # 0811-16). Instead, your firm relies upon certificates of analysis from your suppliers to verify the identity of dietary ingredients used as components in the manufacture of your dietary supplements. You may rely on a certificate of analysis from a supplier, consistent with the requirements in 21 CFR 111.75(a)(2), to confirm the identity of components that are not dietary ingredients and to determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met. But, you may not rely on a certificate of analysis from your supplier to confirm the identity of a component that is a dietary ingredient, unless you successfully petition FDA for an exemption from such testing requirements [21 CFR 111.75(a)(1)].
Your firm failed to establish component specifications for identity, purity, strength, and composition as required by 21 CFR 111.70(b) and product specifications for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). During the inspection, your firm failed to provide any documentation showing that your firm has established the specifications required by 21 CFR 111.70(b) and 21 CFR 111.70(e) for your dietary supplement product C-Complex (1150 mg tablets, Batch # 0811-16).
You firm failed to verify that a subset of your finished batches of dietary supplements that you identify through a sound statistical sampling plan, or every finished batch, meets product specifications for identity, purity, strength, and composition, 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, as required by 21 CFR 111.75(c). Specifically, you did not conduct any finished product testing to verify that established product specifications for strength for your finished dietary supplement product, C-Complex 1150 mg tablets, Batch # 0811-16.
Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch of your C-Complex 1150 mg tablets, Batch # 0811-16, as required by 21 CFR 111.255(b). Specifically, your BPR did not include the following required information:
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 log, where this information is retained, as required by 21 CFR 111.260(c);
Documentation that the finished dietary supplement meets specifications established in accordance with 111.70(e) and (g), as required by 21 CFR 260(i);
Documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k);
Documentation at the time of performance of any required material review and disposition position, as required by 21 CFR 111.260(m);
Documentation at the time of performance of any reprocessing, as
required by 21 CFR 111.260(n).
Your firm failed to follow written established procedures for fulfilling the requirements of 21 CFR, Part 111, Subpart G, as required by 21 CFR 111.53. Your firm established written procedures for fulfilling the requirements of 21 CFR 111.155(a) and (b). Under 21 CFR 111.155(a), your firm is required to visually examine each immediate container or grouping of immediate containers in a shipment that you receive for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the components. Under 21 CFR 111.155(b), your firm is required to visually examine the supplier’s invoice, guarantee, or certification in a shipment you receive to ensure the components are consistent with your purchase order [21 CFR 111.155(b)]. However, your firm did not follow its written standard operating procedures for fulfilling 21 CFR 111.155(a) and (b), which state that all manufacturing and shipping personnel are required to adhere to this written procedure and complete all applicable forms to the fullest extent possible. During our inspection of your facility, eighteen (18) of thirty two (32) records titled “Truck Inspection Form” covering a period from April 1, 2011 through September 27, 2011 were reviewed and observed to not have been completed. This review included Truck Inspection Forms dated May 18, 2011, September 15, 2011, and September 21, 2011 which were found to be missing a QC signature and date of review, and/or product information, and/or were blank.
Your firm did not have the records required under 21 CFR Part 111 regarding the manufacture, labeling, packaging and holding of your dietary supplements, or copies of such records, readily available during the retention period for inspection and copy by FDA when requested, as required by 21 CFR 111.605. For example, you could not provide the batch records for your multivitamin product “The Natural” and for your digestion product “Multi-Enzymes,” as well as records related to personnel, physical plant and grounds, equipment and utensils, quality control, master manufacturing records, laboratory operations, manufacturing operations, packaging and labeling operations, holding and distribution, returned dietary supplements, and complaints which your firm is required to maintain under 21 CFR Part 111. Your firm must keep written records required under 21 CFR Part 111 for one year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records, as required by 21 CFR 111.605.
Your firm failed to make and keep written master manufacturing records for each unique formulation of dietary supplement that you manufacture, and for each batch size, in accordance with 21 CFR Part 111, Subpart P, as required by 21 CFR 111.205(c). During the inspection you could not produce master manufacturing records for each unique formulation of dietary supplement product you manufacture.
Your firm failed to use effective measures to protect against the inclusion of metal or other foreign material in components or dietary supplements as required by 21 CFR 111.365(i). Specifically, a granulating machine used in the production of your finished product dietary supplements from raw material components, does not have an effective means by which metal could be prevented from entering into the finished product. The sieve (approximately .25 square inches) in place between the granulating machine and the V-mixer appeared to be of a size too large to protect against the inclusion of metal fragments into the finished dietary supplement products. Your firm's manufacturing processes do not include the use of filters or strainers, traps, magnets, electronic metal detectors, or any other comparable means to protect against the inclusion of metal or other foreign materials from equipment. This observation remains uncorrected from the previous FDA inspection conducted on September 16 to September 18, 2009.
Unapproved New Drugs
Based on our review of the labeling for your Age-Less Skin Lotion and Poison Ivy Lotion products, we have determined that these products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) and/or (C) of the Act [21 U.S.C. § 321(g)(1)(B)(C)
]. The claims in your labeling for these products establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or to affect the structure or any function of the human body. The marketing of your products with these claims violates the Act.
Examples of some of the claims observed in the labeling for your products include:
Age-less Skin Lotion
“Emu oil has been used . . . to speed healing and diminishing scaring”
“Vitamin C and E have been added as potent antioxidants. They are needed for tissue growth and repair, in the formation of collagen, and may protect against bruising and some wound healing.”
“Age-Less Skin Lotion contains over 20 different herbs and nutrients specific to skin, with anti-inflammatory, collagen building and healing properties.”
“It contains a wide range of natural anti-inflammatory, anti-fungal and anti-bacterial properties to soothe inflammation and fight infection.”
Poison Ivy Lotion
“This formula contains Emu Oil, Sandalwood, Lavender, Eucalyptus, Peppermint, Clove, Chickweed, Witch Hazel, Pau d'Arco and Olive Oil, all having anti-inflammatory . . . properties."
"The Sandalwood, Lavender, Peppermint, Frankincense and Myrrh are antiseptics."
"Burdock Root, Chaparral (as well as being antibacterial) and MSM work as an anti-inflammatory."
"[G]rapefruit seed is anti-microbial, and Nettle and Red Clover have been added for their anti-inflammatory qualities."
Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)
]. Under section 505(a) of the Act [21 U.S.C. § 355(a)
] a new drug may not be legally marketed in the United States without prior approval from FDA in the form of an approved New Drug Application.
We reviewed your responses to the FDA-483 dated from October 20, 2011 through April 23, 2012. Your responses are inadequate because you either failed to appropriately address the applicable violation or you failed to provide supporting documentation showing that your firm has corrected the violation. For example, in your response dated April 9, 2012, you included test results for some of the dietary ingredients that appear to be used in the manufacture of your dietary supplements. These test results did not show that your firm is conducting at least one test or examination to verify the identity of a component that is a dietary ingredient before using such ingredient in the manufacture of your dietary supplements [21 CFR 111.75(a)(1)
]. Another example includes your response dated October 20, 2011, in which you stated that your “Master Batch Records” have a new format with increased controls; however, you did not provide a copy of such records.
This letter is not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action, without further notice, including, but not limited to, seizure and/or injunction of violative products.
We also note that you are required to keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces [21 CFR 111.15
]. However, you did not properly cut weeds or grass within the immediate vicinity of the physical plant so that it does not attract pests, harbor pests, or provide pests a place for breeding, as required by 21 CFR 111.15(a)(1)
. During the inspection, our investigators observed that weeds and shrubbery were dense and growing approximately four to five feet high directly against the eastern side of the building.
Please notify this office in writing within fifteen working days of receipt of this letter as to the specific steps that you have taken to correct the above-listed violations and to ensure that similar violations will not recur. Your response should include any documentation necessary to show that the correction has been achieved. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be made.
Please direct your written reply to the U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180, Attention: Todd Maushart, Compliance Officer. If you have any questions about the content of this letter please contact: Todd Maushart at (781) 587-7486.
Mutahar S. Shamsi
New England District