Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
November 20, 2014
WARNING LETTER NYK-2015-8
VIA OVERNIGHT DELIVERY
Mr. Abu S. Hoque, President & CEO
Long Island Pharmaceuticals, LLC
2231 5th Avenue, Suite 28
Ronkonkoma, NY 11779
Dear Mr. Hoque:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located in 2231 5th Avenue, Suite 28, Ronkonkoma, New York from June 27 through July 3, 2014. Our inspection found that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed or held under conditions that do not meet CGMP requirements for dietary supplements. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
We acknowledge receipt of your response dated July 18, 2014, which included a letter describing your firm’s corrections to the FDA-483 observations along with supporting documentation. Review of your response and related documentation revealed that your firm has not made adequate corrections, as further described in this letter.
The inspection revealed the following significant violations:
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i) unless FDA grants an exemption under 21 CFR 111.75(a)(1)(ii). Specifically, you did not verify the identity of the following dietary ingredients used to manufacture the following finished dietary supplements:
Finished Product/Lot #
Yohimbe extract, Maca Root extract, Epimedium (Horney Goat extract), Muira Puama extract, Eurycoma (Longifolia/Tongkat Ali) Root extract, Tribulus Terrestris, Avena Sativa extract, Panex Ginseng
Zinc, Vitamin B6, Pumpkin Seed extract, Quercetin, Stinging Nettle, Pygeum Africana (Pygeum Bark) extract, Grape Seed extract, MSM (Methyl Sulfonyl Methane), Selenium (Amino Acid Chelate), Silicon dioxide, Fo-Ti extract, Saw Palmetto Berry extract, Pytosterol
Ester C, Calcium, Citrus Bioflavonoid Complex with Hesperidin, Rose Hips powder, Acerola powder, Rutin
Your response dated July 18, 2014 stated that you will verify the identity of all active ingredients (dietary ingredients) to ensure they meet specifications. Your response is inadequate because you stated that identity testing of raw materials will be on a random basis and assay of active ingredients will be on a rotating basis. You must verify the identity of all components that are dietary ingredients before using them, unless you submit a petition to FDA for alternative testing, FDA grants the petition, and you conduct tests and examinations under the terms FDA specifies when the petition is granted (see 21 CFR 111.75(a)(ii)).
2. Your firm failed to verify that your finished batches of dietary supplements meet product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). Specifically, you did not test any of your finished batches of dietary supplements, including (b)(4) and (b)(4), because you stated that your customers are responsible for finished product testing. You also failed to verify that your finished batches of (b)(4) and (b)(4) meet product specifications for limits on those types of contamination that may adulterate or that may lead to the adulteration of the finished batch of dietary supplement, as required by 21 CFR 111.75(c).
Your response dated July 18, 2014 indicated that you will assay for at least one active ingredient in all finished products and conduct microbiological testing for all finished products. However, you did not provide a basis of why testing for at least one active ingredient will ensure the finished batch of dietary supplement will meet finished product specifications. Based on the information you provided, we are not able to assess the adequacy of your corrective action to test for at least one active ingredient in each finished product as a means to verify that your dietary supplement meets product specifications for identity, purity, strength, and composition. Further, it is not clear what microbiological testing you intend to perform for each dietary supplement you manufacture and why the microbes you test for are the types of contamination that may adulterate or lead to adulteration of the finished dietary supplement. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
3. You failed to implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65. Specifically, you failed to develop and implement overall quality control operations and responsibilities in your production processes.
Your response dated July 18, 2014 indicated that you are in the process of hiring a knowledgeable Quality Assurance person to oversee your firm’s quality assurance operations. We intend to verify that adequacy of your corrective action at a future inspection.
4. Your firm used equipment that was not maintained to protect components and dietary supplements from being contaminated by any source, as required by 21 CFR 111.27(a)(3)(v). Specifically, our investigator observed your firm used adhesive tape to hold together food contact surface components of a (b)(4) machine in Room (b)(4), and the tape appeared to have grime adhering to it.
5. Your firm failed to maintain, clean, and sanitize, as necessary, all equipment, utensils, and other contact surfaces used to manufacture, package, label or hold components or dietary supplements, as required by 21 CFR 111.27(d). Specifically, our investigators observed the following conditions on July 1, 2014 after your cleaning logs were completed:
a. Recently cleaned (b)(4) tablet machine in Room (b)(4) appeared to have dust and grime on the food contact surface of the machine;
b. Metal mesh plate that finished tablets come into contact with on the recently cleaned (b)(4) machine in Room (b)(4) appeared to be rusty;
c. Non-food contact surfaces of the recently cleaned (b)(4) machine in Room (b)(4) appeared to have oil, grease, dirt and grime adhering to the surfaces;
d. Recently cleaned (b)(4) tablet machine in Room (b)(4) appeared to have dust and grime adhering to the food contact surfaces of the machine;
e. Recently cleaned (b)(4) tablet coating machine in Room (b)(4) had a yellow and white colored substance adhering to the front of the machine door;
f. Orange powder and dust was observed adhering to the food contact surfaces of the recently cleaned (b)(4) Capsules Filling Machine in Room (b)(4); and
g. Glazed coating machine in (b)(4) appeared to have white powder adhering to the non-food contact and food contact surfaces of the machine; a black glove and a discolored plastic scoop were observed inside of the glazed coating machine.
Your response dated July 18, 2014 indicated that you will be conducting a thorough cleaning of the facility and that the cleaning procedures, tests and specifications will be documented. We intend to verify that adequacy of your corrective actions at a future inspection.
6. You firm failed to collect representative samples, as required by 21 CFR 111.80. Specifically, you do not collect representative samples of raw material supplied by your customers or other components other than dietary ingredients procured by your firm, in-process materials, and finished batches of dietary supplements.
Your response dated July 18, 2014 indicated that you will only be collecting one sample per raw material, due to the small nature of your business and will be sampling finished products following the “square root plus one” scheme. We are unable to assess the adequacy of your response because you failed to provide supporting documents for your corrections. Moreover, FDA notes that, distinct from the requirements for representative samples, you must also meet the requirements for reserve samples set forth under 21 CFR 111.83. Specifically, 21 CFR 111.83(b)(4) requires that reserve samples of each lot of packaged and labeled dietary supplements that you distribute consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.
7. Your firm failed to establish and follow written procedures to review and investigate dietary supplement product complaints, as required by 21 CFR 111.553. Specifically, you stated you did not develop any written procedures to deal with customer complaints because your firm has not received any complaints.
Your response dated July 18, 2014 indicated that you are in the process of setting up a system to record and investigate customer complaints. We intend to verify that adequacy of your corrective actions at a future inspection.
8. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you stated that you do not have written procedures for holding and distributing operations.
Your response dated July 18, 2014 indicated that you are in the process of purchasing and setting up temperature and humidity chart records. However, your response is not adequate because compliance with 21 CFR 111.453 requires that you establish and follow written procedures for holding and distributing operations that include requirements for holding components and dietary supplements (21 CFR 111.455), holding in-process material (21 CFR 111.460), holding reserve samples of dietary supplements (21 CFR 111.465), distribution of dietary supplements (21 CFR 111.470), and records requirements (21 CFR 111.475). We intend to verify that adequacy of your corrective actions at a future inspection.
The violations cited in this letter are not intended to be an all-inclusive statement 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 assure 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 enforcement action without further notice, including, without limitation, seizure and/or injunction.
In addition to the violations cited above, we have the following comments:
1. A dietary supplement manufacturer must maintain the physical plant in a clean and sanitary condition [21 CFR 111.15(b)(1)]. The investigator noted the following observations during the inspection of your firm:
a. Brown dust along the walls of the encapsulation room, Room (b)(4); and
b. Coating on the concrete floors throughout the facility appears to have worn away.
2. A dietary supplement manufacturer must establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that it conducts to determine whether specifications are met [21 CFR 111.303]. We note that there were no written procedures for the in-process examinations and testing that your firm documented for tablet hardness, thickness, and friability. We note that a dietary supplement manufacturer must also establish written procedures for examinations and testing performed to determine whether specifications are met [21 CFR 111.325(b)(1)]. Such a requirement would apply even where a manufacturer sends its product to a testing laboratory to conduct these tests and examinations. In addition, a dietary supplement manufacturer must use adequate tests or examinations to determine whether in-process specifications are met as specified in the master manufacturing record [21 CFR 111.310(b)].
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to reinspection.
Please send your reply to the Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
New York District