- Fragrance Manufacturing, Inc. D/b/a FMI
- Issuing Office:
- Philadelphia District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
January 21, 2015
Mr. Kevin H. Rhodes, CEO
Fragrance Manufacturing Incorporated
100 Cascade Drive
Allentown, PA 18109-9562
Dear Mr. Rhodes:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 100 Cascade Drive, Allentown, PA on March 20, 2014 through April 2, 2014, during which we collected product labeling. Based on the inspection and our review of your product labeling, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
We received your letter, dated April 21, 2014, responding to the form FDA-483, Inspectional Observations that we issued on April 2, 2014. We have reviewed your responses as further discussed in this letter.
Unapproved New Drugs
Based on our review of your Maty’s All Natural Cough Syrup and Maty’s All Natural Cough Syrup for Kids product labeling, we have determined that your products are being promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims made on your products’ labels establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Specifically, the names of your “Maty’s All Natural Cough Syrup and Maty’s All Natural Cough Syrup for Kids” products cause the products to be drugs.
Your Maty’s All Natural Cough Syrup and Maty’s All Natural Cough Syrup for Kids products are not generally recognized as safe and effective and, therefore, are “new drugs” 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Dietary Supplement CGMP Violations
Even if the labeling for your Maty’s All Natural Cough Syrup and Maty’s All Natural Cough Syrup for Kids products did not make therapeutic claims, which make the products unapproved new drugs, these products would still be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act , 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
Specifically, the inspection revealed the following significant violations of the CGMP regulations for dietary supplements:
1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batches of your dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batches of your dietary supplements as required by 21 CFR 111.70(e). Specifically,
- You failed to establish a specification for percent strength of zinc gluconate for finished batches of Maty’s All Natural Cough Syrup and Maty’s All Natural Cough Syrup Kids products
- You have not established a finished product specification limit for yeast and mold plate counts.
In your response, you indicate that you have developed a specification for the zinc gluconate content for this product that will be made part of its release criteria. However, we cannot assess the adequacy of your response because you did not provide documentation to demonstrate your newly established specification for zinc gluconate.
You also indicate that although yeast and mold plate counts were not listed in the finished product specification, testing was conducted and reviewed before releasing the product. Furthermore, you state that effective immediately, the specification of (b)(4) are established, and further identification testing will be conducted on batches that have a result higher than the specification before determining the disposition of that batch. However, we cannot assess the adequacy of your response because you lack documentation to demonstrate the limits established by your firm to ensure the quality of the dietary supplements.
2. You failed to provide adequate documentation of your basis for determining that compliance with specifications you selected will ensure that your finished batch of the dietary supplement meets all product specifications for the limits on those types of contamination that may adulterate, or that may lead to adulteration of, the dietary supplement as required by 21 CFR 111.75(c)(3). Specifically, you lack adequate documentation and/or scientific rationale that demonstrates that your established specification for microbial limits used in the manufacture of Maty’s All Natural Cough Syrup and Maty’s All Natural Cough for Kids will ensure that your finished batch will not be adulterated as a result of such contamination.
We have reviewed your response letter, dated April 21, 2014, and have determined that we cannot assess the adequacy of your response. You do not provide documentation for your basis for determining that there are no harmful micro-organisms in your product. You state in your response letter “The primary ingredient in the Maty's Cough Syrups is honey which can contain naturally occurring, non-harmful micro-organisms”. You also state “Beginning immediately, we are lowering the specifications for acceptable to (b)(4) However, you do not provide adequate documentation for your basis of setting the safe level of microorganism in your product at (b)(4). In addition, you do not provide the type of microorganism or the method you are using to test for them.
In addition, we note your dietary supplement products contain other components which may have contaminants or impurities. You do not provide documentation to demonstrate that such contaminants or impurities are absent from your product. For example, you do not provide evidence that the distilled water you use is safe and of adequate sanitary quality.
3. You did not make and keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, as required by 21 CFR 111.35(b)(2). Specifically,
- Since June 12, 2012, (b)(4) lots of cough syrup products were manufactured, and a total of (b)(4) of the (b)(4) lots were not listed in the cleaning and use log. In addition, the equipment used to produce the cough syrup is shared for filling of “home care” products. As a result, it cannot be determined if cleaning was performed prior to production of each batch or what products were produced on the equipment prior to filling of your cough syrup products.
In your response, you indicated that multiple lots of cough syrup were run immediately after each other, i.e. (b)(4) of the (b)(4) lots. You also stated that you have conducted in-depth training on the correct procedure to document the use, cleaning and sanitizing of the equipment with all appropriate personnel. However, we cannot assess the adequacy of this response because it does not include documentation to demonstrate sequential production of the above product or implementation of your corrective actions.
4. Your quality control operations did not determine whether each finished batch conforms to product specifications established in accordance with 21 CFR 111.70(e), as required by 21 CFR 111.123(a)(7). Specifically, your quality control personnel failed to conduct a review to ensure that the finished product batches of your cough syrup products met specifications prior to release and distribution.
In your response, you state that you have “established a protocol that has a centralized document where all relevant testing results are compiled and reviewed for each FDA regulated product. This document will serve as the final review of results and will subsequently be assigned the acceptance or rejection disposition. Upon the product meeting the specified criteria, this document will be signed off as approval for release of the batch.”
The adequacy of your response will be assessed during future inspections.
The above violations are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, including, without limitation, injunction or seizure.
During the inspection, our investigator also observed deviations from current good manufacturing practice (CGMP) regulations in the manufacture of drug products at your facility. As a manufacturer of human drugs it is your responsibility to assure that any drug products produced are manufactured in conformance with CGMP as delineated in 21 CFR parts 210 and 211.
For example, your firm failed to establish adequate written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, of holding of a drug product, as required by 21 CFR 211.67(b ), in that your firm has not validated the effectiveness of the cleaning procedures used. In addition, your firm failed to establish adequate written procedures for production and process control, as required by 21 CFR 211.100(a), in that none of the manufacturing processes for drug products have been validated to demonstrate that they can produce drug products that consistently have the identity, strength, quality and purity they purport or are represented to possess. Also, your firm has not demonstrated that the equipment used in the manufacture, processing, packing or holding of your drug products is of appropriate design to facilitate operations for its intended use, as required by 21 CFR 211.63, in that your firm has not conducted qualification of the equipment used in the mixing and filling of your drug products. Lastly, your firm failed to establish written procedures for conducting evaluations, at least annually, of the quality standards for each drug product to determine the need for changes to drug product specifications or manufacturing and control procedures, as required by 21 CFR 211.180(e). In response to this letter, please provide documentation of the corrective actions or timeframes for implementation, or any revised procedures referenced in your April 21, 2014 response.
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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We request that you notify this office in writing, within fifteen (15) working days from your receipt of this letter with 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 specific methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to Robin M. Rivers, Compliance Officer, United States Food and Drug Administration, U.S. Customhouse, Room 900, 2nd & Chestnut Streets, Philadelphia, PA 19106. If you have any questions regarding any issues in this letter, please contact Ms. Rivers at 215-717-3076 or e-mail at Robin.Rivers@fda.hhs.gov.
Anne E. Johnson
Acting District Director
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director
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