> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-63/
- Published: 2016-04-19T12:00:00.000Z
- Updated: 2026-09-14T20:55:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135421

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the links following each letter.  
  
**Advanced Vision Science Inc.** Goleta, CA (4/6). Inspected 7/27-8/3/15\. QSR deviations, adulterated: The firm’s complaint handling procedure lacks detail as to how complaints are evaluated for Medical Device Reporting. Its response is inadequate in that it states that it will be reviewing its quality and complaint handling systems. The results of that review have not been provided. Also, the firm does not maintain procedures that address acceptance criteria at customers or its own acceptance criteria \[e.g. tooling marks\]. The design history file does not have the location of design documents or changes the firm made to the (purged) lens, etc. (intraocular lenses devices including, but not limited to, 3-piece and single piece lenses); FDCA 501(h), 501(f)(1)(B), 21 CFR 820.198(a)(3), 820.80(d), 820.30(j)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495539.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495539.htm?ref=fdaweb.com)

  
**Oeyama-Moto Cancer Research Foundation IRB** West Covina, CA (4/7). Inspected 8/11-9/29/15\. Violations: The IRB failed to prepare, maintain, and follow required written procedures governing its functions and operations. Minutes of the 1/18/14 IRB meeting indicate that it “reviewed, agreed on the protocol for IND (purged) in (purged) clinical trial.” However, the minutes do not include documentation of a vote on this action, including the number of members voting for, against, and abstaining. The IRB did not notify the investigator in writing when it approved the “double arm study by coin toss” and “agreed to transfer low dose group patients to high dose group for continuing treatment due to humanitarian reason” on 2/8/14 and also failed to notify the investigator in writing when it took the same action on 4/18/14, etc. (investigational study); 21 CFR 56.108(a)&(b), 56.115(a)(2)&(6), 56.109(e)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm496093.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm496093.htm?ref=fdaweb.com)

  
**Sri Krishna Pharmaceuticals Ltd. - Unit II** Hyderabad, Andhra Pradesh, India (4/1). GMP deviations, adulterated: The firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. The laboratory records did not contain all raw data generated during each test for finished drug products manufactured at the firm. Its quality unit relied on incomplete records to make batch release decisions in support of regulatory submissions to FDA. A QC analyst injected 11 identically or similarly named samples for impurity and assay analysis approximately one to 15 seconds apart from one another, according to the HPLC audit trail for (purged) DMF submission batches (purged), etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.194(a), 211.68(b), 211.100(b), 211.100(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495535.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495535.htm?ref=fdaweb.com)