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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-223/
- Published: 2016-03-01T12:00:00.000Z
- Updated: 2026-09-15T02:39:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134935

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**Argo Medical Technologies, Inc.** Marlborough, MA (9/30). Misbranded: FDA authorized marketing of the ReWalk device under a de novo classification 6/26/14 and ordered Argo to conduct post-market surveillance of the device. Argo’s proposed 522 post-market surveillance study plan synopsis was received by FDA 7/31/14 and the agency informed Argo in a 9/29/14 letter that its submission lacked the information needed to complete the review. FDA received a PS study plan 11/6/14 and informed the company 2/13/15 that the submission also lacked the information needed to complete the review. Several missed deadlines later, the device is misbranded due to the fact that the 15-month time frame within which Argo’s PS study plan must be approved and its study must be commenced closed 9/28/15, etc. (ReWalk device); FDCA 301(q)(1)( C), 21 CFR 822.19, 822.11, 822.20  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm487328.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm487328.htm?ref=fdaweb.com)

  
**Civic Center Pharmacy** Scottsdale, AZ (8/20). Inspected 9/10/14-10/9/14\. GMP violations, adulterated, misbranded, unapproved new drug products: The investigator also noted that the firm produces domperidone products. Domperidone is not the subject of an applicable USP or National Formulary monograph, nor is it a component of an FDA-approved human drug product. Drug products that are intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth. For example, the investigator observed an operator’s arm moving directly over open vials as they were being filled with sterile drug product. Also, the firm did not use sterile disinfectants to adequately disinfect the ISO 5 area, etc. (drug products); FDCA 502(f)(1), 501(a)(2)(A), 501(a)(2)(B), 505(a), 502(f)(1), 501(a)(2)(A), 21 CFR 211.113(b), 211.42(c)(10)(iv)(v), 211.192, 211.167(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm487729.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm487729.htm?ref=fdaweb.com)

  
**Lucy’s Weight Loss System, dba Waisted With Lucy** Arlington, TX (2/17). Inspected own-label distribution facility 9/23/15-10/7/15 and reviewed Web sites at http://waistedwithlucy.com (redirects to http://pinkbikini.bigcartel.com/ and http://lucyscollection.bigcartel.com and https://shortsonthebeach.com (redirects to http://shortsonthebeach.bigcartel.com and social media accounts https://www.facebook.com/Waistedwithlucy/) used to promote its products. FDA confirmed through laboratory analysis that several products contain undeclared active pharmaceutical ingredients including that Pink Bikini (White Capsules) containing diclofenac, Pink Bikini (Blue Capsules) containing sibutramine and Shorts on the Beach (Golden Edition) containing sibutramine and phenolphthalein, etc. (Pink Bikini (White Capsules), Pink Bikini (Blue Capsules), Shorts on the Beach (Blue Capsules), and Shorts on the Beach (Golden Edition); FDCA 505(a), 503(b)(1)(A), 502(f)(1)(2), 502(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm487353.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm487353.htm?ref=fdaweb.com)