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  5. GE PHARMA LLC - 08/26/2014
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WARNING LETTER

GE PHARMA LLC


Recipient:
GE PHARMA LLC


United States

Issuing Office:
New England District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
 
 
WARNING LETTER
 
CMS # 413834
 
 
VIA UPS OVERNIGHT
 
August 26, 2014
 
Gerald R. Loesche, Owner
GE Pharma LLC
55 Middletown Ave
Second Floor
North Haven, CT 06473
                                                                                               
Dear Mr. Loesche:
 
From August 21 to September 13, 2013, the U.S. Food and Drug Administration (FDA) inspected your facility located at 55 Middletown Ave. North Haven, CT 06473. During the inspection, you informed our investigator that your firm has entered into agreements with other firms to manufacture dietary supplement products under your firm’s private labels. Our investigators identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). 
 
These violations cause the dietary supplements manufactured at your facility 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 dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators’ observations were noted on form FDA-483, Inspectional Observations, which was issued to you on September 13, 2013. We also received your correspondence, dated September 26, 2013. The deviations below reflect our response to the observations in the FDA 483, as well as your firm’s correspondence.  
 
Additionally, we reviewed your website at the internet address www.gepharma.com in July 2014, and we have determined that you take orders there for your Performa Test dietary supplement product, which is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
 
FDA has also determined that your Fire Burn, Fire Storm, Creatine, Amino Fire, Nitric Fire, Jet Fire, Oxy Fire, HGH, Cissus, Hydro shield, Performa-Test, Raspberry Ketones, Fire Drol, BCAA 1500, Crea Fuse, and Liquid Fire products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. 343], in that the labels fail to include required information. You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
Unapproved New Drug Violations
 
Examples of some of the website claims that provide evidence that your Performa Test product is intended for use as a drug include:
 
Performa Test
  • “[R]aise total and free testosterone levels”
  • “[H]elps blood sugar stabilization [sic], boosting libido”
 
Your Performa Test product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” 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 the 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.
 
Furthermore, your Performa Test product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Dietary Supplement CGMP Violations
 
Even if your Performa Test product did not have any disease claims which make it a drug, the Performa Test product and the Creatine Ethyl Ester 40X (b)(4), Liquid Fire (b)(4), Firedrol (b)(4), Nitric Fire (b)(4), Pyroburn (b)(4), HGH PM (b)(4), Oxyfire (b)(4), Fireburn (b)(4), and Firestorm (b)(4) products you manufacture are adulterated, based on the following significant violations:
 
1.    Your firm failed to identify personnel to be responsible for your quality control operations, as required by 21 CFR 111.12(b). Furthermore, you failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your firm’s quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
 
During the inspection, you informed our investigator that you were not sure if there were established specifications and explained that the products were originally formulated by your former business partner, and current contract manufacturer, (b)(4) and that he must have the product specifications. You also informed our investigator that you do not have written procedures for the responsibilities of quality control operations, including conducting a material review and making a disposition decision. You did not provide written procedures for the approval for release of your dietary supplements by the quality control personnel. In addition you informed our investigator that you inform (b)(4) what product you want and the quantity of product that is needed. The products are then hand delivered to GE Pharma by an employee of (b)(4). You stated in the affidavit dated September 13, 2013, that all dietary supplement products distributed under the GE Pharma brand are, or were, manufactured by (b)(4).
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1983) (explaining that an offense can be committed under the Act by anyone who has a “responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g), 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
You must implement a system of production and process controls 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 111.55. You must establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations 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 111.105. Furthermore, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement, as required by 21 CFR 111.127(h) and 111.140(b)(2).  However, you informed our investigator that you do not have written procedures for the responsibilities of quality control operations.
 
We have received your response letter, dated September 26, 2013, and have determined your response to be inadequate. You state “GE Pharma is not a dietary supplement manufacturer right now. We dont make our own line, or the private label lines that we sell upon customer request. It’s done for us by our manufacturer(s). We are a distributor of our own line, and Private label lines which are manufactured by other compan(ies) as of right now”. Your response does not address the deficiencies listed above.
 
2.    Your firm also purchases soft gel capsules from a supplier in China for packaging and labeling as a dietary supplement (“Liquid Fire”) that your firm distributes under your own label.  However, your firm failed to establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, in accordance with 21 CFR 111.70(f).
 
Specifically, you stated that you do not have any records related to the purchase of the soft gel capsules from your supplier in China. You stated that you do not have written procedures or records of the bottling and labeling of your “Liquid Fire” product (b)(4). However, you sell this “Liquid Fire” product to online distributors and retailers.
 
We have reviewed your response dated September 26, 2013, and we have determined that your response is inadequate. You state “we are a distributor of our own line, and Private label lines which are manufactured by other compan(ies) as of right now.” Your response did not address the deficiencies listed above.
 
3.    Your firm failed to establish and follow written procedures for packaging and labeling operations, in accordance with 21 CFR 111.403. You firm also failed to make and keep records of these written procedures, in accordance with 21 CFR 111.430. Specifically, you stated that your firm has not established, and does not follow, written procedures for labeling operations of the dietary supplement product Creatine Ethyl Ester 40X (b)(4).
 
We have reviewed your response dated September 26, 2013. Your response states that “GE Pharma is not a dietary supplement manufacturer right now. We dont [sic] make our own line, or the private label lines that we sell upon customer request. Its [sic] done for us by our manufacturer(s). We are a distributor of our own line, and Private Label lines which are manufactured by other compan(ies) as of right now.”We have determined that your response is inadequate because it does not address these deficiencies. 
 
4.    Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 111.553, and for the review and investigation of product complaints, as required by 111.560. Specifically, when discussing the above requirements during the inspection, you informed the investigator that you do not have written procedures for handling product complaints.
 
We have reviewed your response dated September 26, 2013. Your response states that “GE Pharma is not a dietary supplement manufacturer right now. We dont [sic] make our own line, or the private label lines that we sell upon customer request. Its [sic] done for us by our manufacturer(s). We are a distributor of our own line, and Private Label lines which are manufactured by other compan(ies) as of right now.” We have determined that your response is inadequate because it does not address these deficiencies. 
 
5.    Your firm failed to establish and follow written procedures for returned dietary supplements, as required by 111.503. Specifically, when discussing the above requirements during the inspection, you informed the investigator that you do not have written procedures for handling product recalls. There are no written procedures to be followed when any product is returned, including procedures for handling returned dietary supplements that must be destroyed or otherwise suitably disposed of in accordance with 111.515, and for returned dietary supplements that may be salvaged in accordance with 111.520. 
 
We have reviewed your response dated September 26, 2013. Your response states that “GE Pharma is not a dietary supplement manufacturer right now. We dont [sic] make our own line, or the private label lines that we sell upon customer request. Its [sic] done for us by our manufacturer(s). We are a distributor of our own line, and Private Label lines which are manufactured by other compan(ies) as of right now.” We have determined that your response is inadequate because it does not address these deficiencies.  
 
6.    Your firm failed to establish and follow written procedures for holding and distributing operations, in accordance with 21 CFR 111.453. In addition, your firm failed to make and keep records of these written procedures in accordance with 21 CFR 111.475.
 
Specifically, you stated that you have no written procedures for holding and distribution procedures to ensure that dietary supplements are held under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the dietary supplements are not affected (see 21 CFR 111.455(a)). We have reviewed your response dated September 26, 2013. Your response states that “GE Pharma is not a dietary supplement manufacturer right now. We dont [sic] make our own line, or the private label lines that we sell upon customer request. Its [sic] done for us by our manufacturer(s). We are a distributor of our own line, and Private Label lines which are manufactured by other compan(ies) as of right now.” We have determined that your response is inadequate because it does not address these deficiencies. 
 
Misbranded Dietary Supplement:
 
1.    Your Fire Burn, Fire Storm, Amino Fire, Jet Fire, Oxy Fire, HGH, Cissus, and Liquid Fire products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because they fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
2.    Your Fire Burn, Fire Storm, and Raspberry Ketones, products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance 21 CFR 101.36. Specifically, your Fire Burn product does not contain an “ingredient list.”
 
3.    Your Fire Burn, Fire Storm, Creatine, Amino Fire, Nitric Fire, Jet Fire, Oxy Fire, HGH, Cissus, Hydro shield, Performa-Test, Raspberry Ketones, Fire Drol, BCAA 1500, Crea Fuse, and Liquid Fire products are misbranded within the meaning of sections 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the label fails to identify the products using the term dietary supplement, in accordance with 21 CFR 101.3(g).
 
4.    Your Fire Burn, Fire Storm, Creatine, Amino Fire, Nitric Fire, Jet Fire, Oxy Fire, HGH, Cissus, Hydro shield, Performa-Test, Raspberry Ketones, Fire Drol, BCAA 1500, Crea Fuse, and Liquid Fire products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the label fails to bear nutrition labeling in the proper format, which is required under 21 CFR 101.36. Specifically, the nutrition information on your Fire Burn product does not include the (b)(2) dietary ingredients or a % Daily Value column. 
 
5.    Your Fire Burn, Fire Storm, Amino Fire, Nitric Fire, Jet Fire, HGH, Cissus, Performa-Test, and Raspberry Ketones productsare misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)] in that the labels fail to identify the part of the plant from which the dietary ingredient is derived, in accordance with 21 CFR 101.4(h)(1).
 
6.    Your Pyroburn, Fire Burn, Fire Storm, Creatine, Amino Fire, Nitric Fire, Oxy Fire, HGH, Cissus, Hydroshed, Performa-Test, Raspberry Ketones, BCAA 1500, and Liquid Fire products are misbranded within the meaning of sections 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a current domestic address or domestic phone number through which the responsible person as described in section 761(b) of the Act [21 U.S.C. § 379aa-1(b)], may receive a report of a serious adverse event associated with the product.
 
This letter is not intended as an all-inclusive list of the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the dietary supplements CGMP regulations. You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and injunction.
 
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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made. 
 
Your reply should be sent to the following address:
 
Rory Geyer
Compliance Officer
U.S. Food and Drug Administration
One Montvale Ave
Stoneham, MA 02180
 
If you have questions regarding this letter, please contact Rory K. Geyer, Compliance Officer at 781-587-7521 or rory.geyer@fda.hhs.gov.
 
Sincerely,
/S/
Mutahar Shamsi
New England District Director