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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-74/
- Published: 2016-07-19T12:00:00.000Z
- Updated: 2026-09-14T21:15:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136231

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**GenPak Solutions, LLC** Hilliard, OH (7/12). Inspected 8/3, 4, and 5/2015 and 8/7, 8/12/15\. GMP deviations, adulterated, misbranded, unapproved new drug: The inspection revealed that the firm repackages, relabels, and distributes unapproved new drugs. The firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product. GenPak also currently assigns expiration dates to repackaged products using either the manufacturer’s expiration date or a date one year from the date of repackaging, whichever is later. This practice can result in the assignment of expiration dates that exceed six months from the date of repackaging, and it has not conducted stability studies to support the assigned dates, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 505(a), 21 CFR 211.67(a), 211.166, 211.100(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511703.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511703.htm?ref=fdaweb.com)

**MC-Cor, LLC** San Juan, Puerto Rico (6/30). Reviewed Web site at www.metacorllc.com/en in June and determined that the firm takes orders there for the product “GlucoCoR” capsules. Unapproved new drug, misbranded: “GlucoCor” is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner, etc. (GlucoCoR); FDCA 502(f)(1)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511558.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511558.htm?ref=fdaweb.com)

**Oscor, Inc.** Palm Harbor, FL (6/13). Inspected 2/29-3/17\. QSR deviations, adulterated: The firm’s use of Single Lot Release for the EO sterilization processing of the Maestro Rechargeable System does not provide assurance that sterility requirements for the device are met. Also, the firm does not monitor the environmental conditions, i.e. temperature and humidity conditions, in cleanroom (purged) where the (purged) process is conducted for the Adelante Magnum devices, etc. (introducer catheters, i.e., Adelante Magnum, and a neuromodulator for obesity, i.e.,Maestro Rechargeable System); FDCA 501(h), 21 CFR 820.70(a)&(c), 820.75(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm509968.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm509968.htm?ref=fdaweb.com)

**SmithKline Beecham Ltd.** Middlesex, UK (6/30). CGMP deviations, adulterated: FDA investigators documented findings of penicillin in non-penicillin manufacturing areas about 69 times in 2012, 72 times in 2013, 30 times in 2014, and 16 times through 7/7/15\. The facility and controls to prevent contamination of non-penicillin drugs with penicillin are wholly inadequate. The company also failed to adequately investigate critical deviations and implement corrective and preventive actions. For example, from 4/20/14-2/17/15 the firm investigated at least 25 breaches of the alert level or action level for microbial contamination in its water system loops in Building (purged). It used water produced from this system to manufacture (purged) API. The firm identified Burkholderia cepacia, a waterborne organism known to contribute to biofilm formation in water systems, in several of its alert-level and action-level investigations, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511838.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511838.htm?ref=fdaweb.com)

**TerraVare, Inc.** Black Mountain, NC (7/12). CGMP deviations, adulterated: The firm did not have any quality control personnel employed during FDA’s inspection. It failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use. Also, the firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that it manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, etc. (dietary supplements); FDCA 403(q)(5)(F), 21 CFR 111.12(b), 111.75(a)(1)(i), 111.255(b), 111.260, 111.205(a), 111.123(a)(2)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511583.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511583.htm?ref=fdaweb.com)