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U.S. Department of Health and Human Services

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Enforcement Actions

Desert Rose Manufacturing 3/1/13

  

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

Public Health Service
Food and Drug Administration
 
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000              
FAX:        303-236-3100

 

March 01, 2013
 
 
Ref: DEN-13-9-WL
 
WARNING LETTER
 
 
VIA UPS OVERNIGHT MAIL
 
Gene S. (Sylvester) Eagle-Oden, Co-Owner/President
Gene S. (Susan) Eagle-Oden, Co-Owner/Vice President
Desert Rose Manufacturing, Inc.
1810 Washington Street
Anthony, NM 88021
 
 
Dear Mr. & Mrs. Eagle-Oden:
 
On July 10-12, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 1810 Washington Street, Anthony, New Mexico. Our investigator found a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
 
Adulterated Dietary Supplements
 
The inspection revealed that your nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX products manufactured in your facility, are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our inspection on July 12, 2012.
 
The inspection revealed the following violations:
 
1.    You failed to establish specifications as required by 21 CFR 111.70 as follows:
 
  • A specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.70(a)];
  • Component specifications for each component used in the manufacture of a dietary supplement to include:
 
o   Identity specifications [21 CFR 111.70(b)(1)],
o   Specifications to ensure the purity, strength and composition of the dietary supplements manufactured using these components are met [21 CFR 111.70(b)(2)], and
o   Specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)];
 
  • In-process production specifications to include:
 
o   Specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement [21 CFR 111.70(c)(1)],
o   Adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement [21 CFR 111.70(c)(2)], and
o   Review and approval of the documentation required under 21 CFR 111.70(c)(2) by quality control personnel [21 CFR 111.70(c)(3)];
 
  • Product specifications for each dietary supplement that you manufacture for the identity, purity strength, and composition of the finished batch of the dietary supplement, 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 to ensure the quality of the dietary supplement [21 CFR 111.70(e)].
 
Specifically:
  • Your firm has no records of any specifications for the identity, purity, strength and composition of your raw materials such as vitamins, minerals, and botanicals that you use in the manufacture of your nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX products.
  • Your firm has no records of any specifications for potential contaminants or limits for potential contaminants for nuphedrine, Lithium Orotate, cleanseRX II, and zialipro finished dietary supplements.
  • The finished product cleanseRX II contains 21 vitamins and minerals; however, you have not provided records of any specifications for the identity, purity, strength, or composition of the raw material or the finished product.
 
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and September 12-15, 2011. We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. You state that you are currently in the process of reviewing specifications for raw materials, in-process blends, bulk material, and finished goods as you work to define appropriate testing methods for each specification. You also state that you will complete updating your MMR once specifications and testing methods have been defined for each stage of production. You provided no documentation of any product specifications to ensure the quality of your dietary supplements ((21 CFR 111.70(a)).
 
2.   You must first establish component, in-process, and finished product specifications, which you have failed to do, in order to comply with the requirements in 21 CFR 111.75 to ensure that your established specifications are met. Specifically:
  • You failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use as required by 21 CFR 111. 75(a)(1)(i). We note that you must first establish an identity specification for each component, as required by 21 CFR 111.70(b), so that you can verify that such specification is met. Identity testing (ID) in-house is not conducted due to laboratory equipment failure. Even though you have purchased new equipment, a (B)(4), it is not operational due to issues relating to the (B)(4). Furthermore, your firm did not send the raw materials to an outside laboratory for identity testing when your equipment failed. The lack of testing affects all (B)(4) lots of finished products manufactured in the past year.
  • You failed to confirm the identity of other components and determine whether other applicable specifications were met by either conducting appropriate tests or examinations or relying on a certification of analysis, as required by 21 CFR 111.75(a)(2). 
 
o   Specifically, even though your firm receives a supplier’s certificate of analysis, your firm has not established specifications that the supplier must meet nor qualified your supplier, as required by 111.70(b) and 111.75(a)(2)(ii). You have not established the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier 's test or examinations, as required by 21 CFR 111. 75(a)(2)(ii)(A).
o    Raw materials that are received at your facility do not undergo any testing or confirmation to ensure the materials meet your specifications and to confirm the reliability of the material received against the Certificate of Analysis (COA).
 
  • Your firm releases raw materials for use in manufacturing based on the Certificate of Analysis (COA) even though there are no established specifications that the COA is to meet, and the COA does not include a description of the test methods used, limits of the test, and signature and date from the vendor as required by 21 CFR 111.75(a)(2)(ii)(B).
o   Specifically, we reviewed the COA of zialipro (lot 20441); two of the raw materials selected for review failed to include required information. The third ingredient Red Panax Ginseng's COAs provided did not match the lot numbers used in the Batch Record.
  • You failed to verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, 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 for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch) as required by 21 CFR 111.75(c).
 
o   Specifically, you have not established finished product specifications, as required by 21 CFR 111.70(e), nor conducted any testing to demonstrate that your products, nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro, and cleanse RX meet finished product specifications, as required by 21 CFR 111.75(c).
 
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and September 12-15, 2011.
 
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. You state in your letter that your (B)(4) machine is now operational and you are in the process of training new quality control staff in its use for testing identity of raw materials and representative samples, and that you are also in the process of training quality control staff to conduct other inspections and physical testing of materials at each stage of production to verify that materials meet other established specifications. This response is inadequate because you provided no documentation of any product specifications to ensure the quality of your dietary supplements ((21 CFR 111.70(a), nor any documentation of testing, including qualification of your suppliers, as required by 21 CFR 111.75.
 
You also state that these inspections are currently conducted and documented by production staff and that formal testing and release procedures will soon be implemented and documented by quality control staff.  However, you have not provided FDA with documentation of the completed inspections. Hence, FDA could not determine the adequacy of these inspections.
 
3.   Your quality control personnel failed to perform required operations to 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. To ensure the “quality” of your dietary supplements, you must establish specifications for the identity, purity, strength, and composition of your dietary supplements, among other requirements (see 21 CFR 111.3 for definition of “quality”). Therefore, in part, because you have no established specifications, your quality control personnel also failed, for example, to approve or reject the processes and specifications, as required by 21 CFR 111.105(a). For example, the quality control personnel must review and approve the documentation setting forth the basis for why determining compliance with selected finished product specifications for testing or examination under 21 CFR 111. 75(c)(1) will ensure that the finished batch of dietary supplement meets product specifications (21 CFR 111.105(d)). In addition, to the extent you exempt one or more product specifications from the verification requirements in 111.75(c)(1), you must document why, for example, any component and in-process testing, examination, or monitoring, or other methods will ensure that such exempted product specifications is met without verification through periodic testing of the finished product (see 21 CFR 111.75(d)(1)), and the quality control personnel must review and approve the basis you set forth, as required by 21 CFR 111.105(e).
 
Specifically, nuphedrine, Bromelain with papain, alfa PXP Plus, Lithium Orotate, and zialipro, as well as all (B)(4) lots of finished dietary supplements manufactured by your firm, have no documentation regarding what the finished product specifications are (see § 111.70(e)), nor what finished product specifications you use to verify that your finished batch of dietary supplement meets product specifications (see § 111.75(c)). This information is necessary so that the quality control personnel can review and approve the documentation you use to verify that your finished batch meets product specifications for the identity, purity, strength, composition, and limits on contamination, as required by 21 CFR 111.105(d) and (e), and can approve or reject processes, specifications, written procedures, and controls, for example, that may affect the identity, purity, strength or composition of your dietary supplements, as required by 111.105(a). 
 
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and September 12-15, 2011.
 
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. You state in your letter that your quality control staff currently reviews all batch record documentation, including in-process, bulk pill, and finished goods worksheets, and that they will be trained to review testing results and to document disposition decisions based on those results once testing methods have been defined. This response is inadequate because you provided no documentation of any product specifications to ensure the quality of your dietary supplements (21 CFR 111.70(a)), finished product specifications (see 21 CFR 111.70(e)), or what finished product testing you do to verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contaminants that may adulterate or lead to adulteration of the finished batch (21 CFR 111.75(c)). 
 
You also state that your batch record has been updated to document the quality control release decision for raw materials and components, in- process blends bulk pills, finished products, and any corrective actions initiated. However, you have not provided FDA with documentation of any product specifications to ensure the quality of your dietary supplement, nor updated batch records and records of related quality control operations. Hence, FDA could not determine the adequacy of the quality control procedures. 
 
4.   Your firm’s batch production records (BPRs) did not include complete information relating to the production and control of each batch of your dietary supplement products as required by 21 CFR 111.260. Specifically:
 
  • The batch production records for the following dietary supplements were incomplete: nuphedrine (lot #00807); Bromelain with papain (lots #10818, #00166, and #00660); alfa PXP Plus (lot #10501); Lithium Orotate (lots #10707and #10312); and zialipro (lots #10716 and #10717). These BPRs were missing the following:
 
o   The results of any testing or examination performed during the batch production, or cross-reference to such results, as required by 21 CFR 111.260(h).
o   Documentation that finished product met specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i).
o   Documentation at the time of performance of any required material review and disposition decision as required by 21 CFR 111.260(m).
 
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and September 12-15, 2011.
 
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. You provided no product specifications to ensure the quality of your dietary supplement, on which the testing or examination results of the finished batch are based, or missing documentation (identified above) for the batch production record for each of the dietary supplements identified. You state in your letter that you currently document all cleaning and control logs for equipment with reference to batch numbers for products made that day, and that your quality control staff approves the use of rooms and equipment before product is made. However, you have not provided FDA with the documentation of your cleaning and control logs for equipment with reference to batch numbers for products made that day. Hence, FDA could not determine the adequacy of the quality control procedures for cleaning and for control logs for equipment.
 
Your letter also states that calibration records for routine maintenance are kept and reviewed by quality control/document control. However, you have not provided FDA with the documentation of the calibration records. Hence, FDA could not determine the adequacy of the calibrations.
 
5.   You failed to collect representative samples of a subset of finished batches of dietary supplements that you manufactured before releasing for distribution to verify that the finished batch of dietary supplement meets established product specifications as required by 21 CFR 111.80(c). Specifically, you failed to establish finished product specifications (21 CFR 111.70(e)) and did not collect the required samples before distribution to verify that the finished batches of (B)(4) lots/batches of nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro, and/or cleanseRX met product specifications established under § 111.70(e), and as applicable, § 111.70(a). We note that, as required by 21 CFR 111.123(b)(2), the quality control personnel must not approve and release for distribution any batch of dietary supplement that does not meet all product specifications established under § 111.70(e). We also note that the failure to collect representative samples for finished product testing is a repeat violation cited in two previous inspections, July 22-27, 2010, and September 12-15, 2011.
 
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. You state that you redesigned your batch record to include documentation of sample collection and in-process blends for finished goods, and redesigned your batch record to include documentation of testing and testing results. However, you have not provided FDA with your revised batch records or product specifications. Therefore FDA could not evaluate whether your revised batch records for these dietary supplements address the failure to collect representative samples, as described in the citation above.
 
6.   Your firm does not use effective measures to protect against the inclusion of metal or other foreign material in dietary supplements as required by 21 CFR 111.365(i). Specifically, there is no method used by your firm to ensure metal fragments have not been introduced into the product after the use of tablet presses and mechanical encapsulation equipment where metal contamination is reasonably likely to occur.
 
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. You state that you "have re-purposed and conducted initial testing trials on our (B)(4) metal detector". You also state that this is a very strong magnet and you have shown that bulk pills will be held to the surface of the magnet when passed over it if the pill contains any metal contaminants. However, you have not provided FDA with any documentation of these tests. Hence, FDA could not determine the sufficiency of these initial testing trials.
 
7.   Your firm did not have all the records required or copies of such records readily available during the retention period for inspection and copying by FDA as required by 21 CFR 111.605(a) and (b). Your firm does not have written procedures for operations as required by 21 CFR Part 111. For example:
  • No established in-house specifications for raw materials, in-process materials, or finished products for identity, purity, strength, or composition, as required under 21 CFR 111.95(a) and (b).
  • No written procedures for holding and distribution, as required under 21 CFR 111.475(b).
  • No written vendor qualification program, as required under 21 CFR 111.95(b)(2).
  • No written release criteria for finished goods and no documentation of quality review before distribution, as required under 21 CFR 111.95(b)(4) and 111.110(c).
  • No maintenance records for equipment utilized in manufacturing, as required under 21 CFR 111.260(c).
 
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be inadequate. All your responses to the violations cited above lack documentation of your stated actions, or do not contain a time line for implementation. For example, you state in your letter that updated SOPs will be written once new procedures are implemented. This response is inadequate because you do not provide a time line for implementation of the new procedures.
 
We include the following comments:
 
Your firm includes a shelf life on the labels for your dietary supplement products, including, but not limited to, Yohimbe Extract, Calcium 0-Pantothenate, and Red Panax Ginseng Powder products. Any shelf life you place on a product label should be supported by data that demonstrate the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
 
Your firm failed to keep paper towels and/or toilet tissue in the production area and the men’s toilet in the production area did not flush. Due to the condition of the restrooms, the sink area, and the lack of hands free faucets, contamination is reasonably likely to occur. See the applicable requirements in 21 CFR 111.15(h).
 
Misbranded Dietary Supplements:
 
Your zialipro, alfa PXP Plus, and cleanseRX products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Your cleanseRX and alfa PXP Plus labels fail to present nutrition information in the form of a supplement facts panel.
 
Your alpha PXP Plus product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
Your zialipro product label is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] and in accordance with 21 CFR 101.4(h). For example, you do not list the name of the part of the plant in English from which the dietary ingredient is derived for Tribulus Terrestris, Epimedium Sagittum, Yohimbe extract, and Muira Pauma.
 
Your cleanseRX product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105
 
Your alfa PXP Plus product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
 
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market 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.
 
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 in the future. 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Carolyn A. Pinney at (303) 236-3024.

 
Sincerely,
/S/ 
LaTonya M. Mitchell
Denver District Director