Inspections, Compliance, Enforcement, and Criminal Investigations
Pharmline, Inc. 5/25/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
May 25, 2010
WARNING LETTER NYK 2010-18
VIA UNITED PARCEL SERVICE
Mr. John J. Witterschein, CEO
41 Bridge Street
Florida, NY 10921
Dear Mr. Witterschein:
We inspected your facility, located at 41 Bridge Street, Florida, New York on January 14, 15, 20, 21 and February 3, 2010. During the inspection, our investigator found that you have serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.
Our inspection revealed that you received (b)(4) kg of gamma-treated spirulina powder from your supplier (b)(4), and that you also received (b)(4) kg of non-gamma-treated spirulina powder from the same supplier and sent (b)(4) lbs of this lot (designated as lot (b)(4) to your contracted irradiation facility, (b)(4) for gamma irradiation treatment. Under section 402(a)(7) of the Act (21 U.S.C. 342(a)(7)), a food is adulterated if it has been intentionally subject to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Act. There is no regulation or exemption in effect pursuant to section 409 for spirulina powder (see 21 CFR 179.26). Therefore, your spirulina powder is adulterated under section 402(a)(7) of the Act because it received radiation treatment and there is no FDA regulation or exemption permitting the use of radiation for this product.
Further, your Saw Palmetto Extract 30% product is misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients, but the label fails to bear the common or usual name of each ingredient, as required by 21 CFR 101.4(a)(1). Specifically, your master manufacturing record shows that this product contains dicalcium phosphate dihydrate, sorbitol, maltodextrin, and calcium silicate, but these ingredients are not declared on the label of the product.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you manufacture and distribute comply with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
We acknowledge receipt of your February 18, 2010, responses to the FDA-483.
With respect to your response to observation 1, we want to remind you that there is no FDA regulation authorizing the use of irradiation for foods, including dietary ingredients, such as vitamins, minerals, and herbs or other botanicals. The records that our investigator collected indicate that your firm regularly irradiates these types of products. FDA is concerned with the possible effects of the radiation on the nutrients in the food, the production of radiolytic byproducts, and the potential effect of radiation on the microbiological profile of the food. Any of these issues could raise health concerns with your irradiated products.
In addition, if you are manufacturing a dietary supplement, including a dietary supplement that you manufacture but that is packaged or labeled by another person, you are subject to 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
Further, we acknowledge your responses to the FDA 483 for observations 2 and 3 and will verify your corrective actions during our next routine inspection of your facility.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, 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