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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-215/
- Published: 2016-01-05T12:00:00.000Z
- Updated: 2026-09-15T02:25:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134345

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**Cadila Healthcare Ltd.** Ahmedabad, India (12/23/15). Inspected two pharmaceutical manufacturing facilities in 2014: Sarkhej-Bavla Road, N.H. No. 8A, Moraiya, Tal. Sanand, Ahmedabad, Ahmedabad City 8/28-9/5/14 and Plots 265-266 B Zyfine Unit, Sarkhej-Bavla Road, N.H. No. 8A, Changodar, Tal. Sanand, Ahmedabad 12/1-6/14\. GMP deviations, adulterated: The firm did not adequately investigate out-of-specification (OOS) laboratory test results. For example, several OOS investigation reports associated with potency and content uniformity specifications for warfarin sodium, failed to identify a root cause or provide adequate corrective actions. On 11/29/14, Cadila informed FDA that, based on protocols executed and various experiments performed, it decided to resume the manufacture of warfarin sodium tablets on 11/24/14, however, months later, in a meeting with FDA on 6/8/15, the firm acknowledged that additional lots had failed since it resumed the manufacture of warfarin sodium tablets in 11/2014\. Also, the inspection found that the firm did not adequately investigate and address consumer complaints on multiple occasions, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.192  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479712.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479712.htm?ref=fdaweb.com)

  
**CrystalBraces Limited Liability Company** Dallas, TX (10/30/15). Inspected facilities at 2515 McKinney Avenue, Dallas, TX and 3211 W. Northwest Highway, Suite 200, Dallas, TX 9/16-23/15\. QSR deviations, adulterated: The firm has written and approved several design control procedures for establishing and documenting design inputs, outputs, reviews, verification, validation and transfer. Each of these procedures have an effective date of 6/18/15, but during the inspection, the firm could not provide any records to demonstrate that these procedures have been implemented. Also, the firm has not established procedures to control its (purged) process used to create the mold for the dental aligners or the (purged) used to mold and harden the finished devices. It does not have any procedures that provide instructions for the methods used to control manufacturing, etc. (CrystalBraces dental aligner); FDCA 501(h), 21 CFR 820.30(a), 820.70(i), 820.70(a), 820.75(a), 820.181, 820.50, 820.184, 820.80(b)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478989.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478989.htm?ref=fdaweb.com)

  
**LivaNova (**formerly **Sorin Group S.p.A.)** Milano, Italy (12/29/15). Inspected Sorin Group Deutschland GmbH, Munchen, Germany, 8/24-27/15 and Sorin Group USA, Inc., Arvada, CO 8/24-9/1/15\. QSR deviations, adulterated: At the Munchen facility, the firm failed to establish and maintain procedures for identifying, documenting, validating, or where appropriate verifying, review, and approval of design changes before their implementation. For example, a changed design input is incomplete in that there is no information on how maintaining a cleanliness standard for drinking water applies to the requirement that “biofilm should not grow in the 3T devices”. Also, there is no information on a water quality standard ensures that the device does not cause waterborne infection. At the Arvada facility, the firm’s MDR procedure updated on 10/15/12 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. Significant labeling changes for the Heater-Cooler System 3T, cleared under K052601, that can affect the safety or effectiveness of the device, require a new 510(k), etc. (Stockert Heater Cooler 3T thermal regulator devices); FDCA 501(h), 501(f)(1)(B), 21 CFR 820.30(i), 820.75(a), 803.17  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm?ref=fdaweb.com)

  
**SonicLife.com, LLC** Hood River, OR (12/22/15). Inspected 6/1/15-7/2/15\. Misbranded: Devices are being marketed without required clearance (whole body vibration devices that include Professional VC-12, Pulsation VM-10, and Personal VH-11); FDCA 501(f)(1)(B), 515(a), 502(o)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478988.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478988.htm?ref=fdaweb.com)