Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Advanced MicroVas II LLC Broken Arrow, OK (6/30). Inspected 7/9-11/18/13. QSR deviations, adulterated, misbranded: The firm is the specification developer for the Micro VAS8110 and has not established procedures for design inputs, design outputs, design verification, design validation, design changes, or design history files. It does not have an approved PMA or IDE. The firm has also failed to adequately develop, maintain and implement written MDR procedures, etc. (Micro VAS8110 devices); FDCA 501(h), 501(f)(1)(B), 21 CFR 820.30(a), 820.198, 820.50, 820.22, 820.181, 803.17.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm413354.htm
Descor, LLC Parkersburg, WV (8/19). Unapproved new drug, misbranded. The firm distributes to consumers and other distributors via its Web site, www.assetcapsules4u.com. FDA confirmed through laboratory analyses that a sample of “Asset Bee Pollen” contained undeclared sibutramine, the active pharmaceutical ingredient in Meridia, a prescription drug for treating obesity, which was withdrawn due to risk of heart attack and stroke. The labeling for this drug fails to bear adequate directions for use, etc. (Asset Bee Pollen); FDCA 502(f)(1), 502(a), 502(j)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm413627.htm
Health Science Products, Inc. Hueytown, AL (8/27). Inspected 1/9-23. QSR deviations, adulterated: The firm failed to establish procedures for corrective and preventive action. For example, the CAPA procedure primarily quotes the subparts of the QS regulations and does not provide specific, step by step instructions and specifications to initiate a CAPA. The procedure does not include reporting forms or address possible outcomes for CAPA dispositions or who’s responsible for these actions. The firm also failed to develop written MDR procedures. (Class I dental chairs and dental operative unit); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(a), 820.50, 820.184, 820.181, 820.80(e), 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm413363.htm
John W. Hollis Inc., dba John Hollis Pharmacy Nashville, TN (9/4). Inspected 2/4-3/21. GMP violations, unapproved new drugs, adulterated, misbranded: The investigators noted that the pharmacy was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. The facility was not physically designed and environmentally controlled to minimize airborne contamination, and the ISO 5 hood was located in an unclassified area. The firm did not adequately monitor and control the microbial and particulate quality of the environment and personnel. Also, the flow and handling of materials that were placed in the ISO 5 hood posed an unacceptable contamination hazard, etc. (drug products); FDCA 505(a) and 502(f)(1), 501(a)(2)(A)&(B), 21 CFR 211.42(c)(10)(iii), 211.166(a), 211.113(b), 211.42(c)(10)(iv), 211.167(a), 211.28(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm413324.htm
Orgsyn Laboratory Inc. Northbrook IL (8/26). The owner of the facility has failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012. FDCA 379j-41to 379j-42
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm413335.htm
