Latest FDA Warning Letters

Buderer Drug Company, Inc. Perrysburg, OH (9/20). FDA inspected the firm in January and documented that it was not receiving valid prescriptions for individually-identified patients for compounded drugs. In addition, an agency investigator observed serious deficiencies in the firm’s practices for producing sterile drug products. For example, the investigator observed partially stoppered vials being transferred from the ISO 5 area through the ISO 7 area.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525872.htm

Colabs International Corp. Las Vegas, NV (10/19). FDA inspected the firm 11/2015 and found that its Klēnskin sunscreen products are unapproved new drugs because the products are ineligible for the OTC Drug Review for Sunscreens and are not generally recognized as safe and effective for use to help provide protection from sunburn.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526205.htm

Diamond Wipes International, Inc. Chino, CA (10/19). FDA inspected the firm 11/2015 and determined that its “LA Fresh travel-lite Sunscreen Wipe SPF 30” is an unapproved new drug because the product is ineligible for the OTC Drug Review for Sunscreens and it is not generally recognized as safe and effective for use to help provide protection from sunburn.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526269.htm

ITW PRO Brands Olathe, KS (10/19). FDA has determined that the company’s “Scrubs Solar Guard Sunscreen Wipe SPF 30+” and “Scrubs Hand Sanitizer Wipes” are unapproved new drugs. The sunscreen wipe is an unapproved new drug because the product is ineligible for the OTC Drug Review for Sunscreen and it is not generally recognized as safe and effective. Additionally, claims made for the hand wipes cause the product to be an unapproved new drug because they suggest the intended use is for diagnosis, cure, mitigation, treatment, or prevention of disease.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526069.htm

Interpharm Praha A.S. Modrany, Czech Republic (10/18). FDA inspected the firm 10/2015 and documented significant deviations from GMP practice for active pharmaceutical ingredients and significant violations of GMP regulations for finished pharmaceuticals. For example, the quality control unit did not have basic controls to prevent changes to the firm’s electronically-stored laboratory data. During the inspection, an audit trail was examined for 8,906 entries. Of these, well over half indicated some form of data deletion or manipulation, including at least 1,441 instances of deleted results, at least 3,643 instances of manual integration, and at least 194 instances of altered running sample sets.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525748.htm

Meditech Laboratories, Inc. Las Vegas, NV (10/19). FDA inspected the firm in March and observed serious deficiencies in the firm’s practices for compounding sterile drug products. Specifically, investigators observed stains on the HEPA filters in the firm’s laminar airflow hood where sterile drug production occurred. Also, the firm did not measure pressure differentials during operations and therefore it has no assurance that airflow is from areas of higher quality air to areas of lower quality air.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526116.htm

NuVet Laboratories Westlake Village, CA (7/29). FDA reviewed the firm’s marketing of numerous products as “nutritional supplements” for animals and concluded, based on product claims, that they are unapproved new animal drugs. Affected products include NuVet Plus Canine Wafers, NuVet Plus Canine Powder, and NuVet Plus Feline, NuJoint Plus, NuJoint DS, and NuVet Labs Ear Cleaner.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525952.htm

Osea Intl. Malibu, CA (9/27). FDA reviewed the firm’s Web site (http://oseamalibu.com/) and determined its products Blemish Balm, Essential Corrective Complex, Brightening Serum and Sea Vitamin Boost are unapproved new drugs based on claims it made on the site.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525345.htm

Proprietary Wellness Clinton Township, MI (9/27). FDA has determined that the dietary supplements marketed by the firm are misbranded because they do not comply with the labeling requirements for such products. The agency also found that the ingredients declared in the products are not recognized dietary ingredients within the definition set forth in regulations.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525961.htm

Teva Pharmaceutical Works Pvt. Ltd. Petah Tikva, Israel (10/13). FDA inspected a Hungary facility in January and documented significant GMP violations for finished pharmaceuticals. For example, the facility did not adequately investigate media fill and sterility test failures. During the inspection, investigators observed poor aseptic processing techniques that had been previously videotaped at the facility. Additionally, the firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525640.htm