Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2017
Divi's Laboratories received an FDA warning letter concerning Unit II
The United States Food and Drug Administration issued a warning letter after an inspection of the company's Unit II facility. The letter cited deficiencies involving laboratory controls and electronically stored data in the context of current good manufacturing practice. The FDA also referenced import alerts and possible restrictions until corrective actions were completed.
2017
United States FDA warning letter concerning Unit II
Following an inspection of the Unit II facility, the United States FDA cited deficiencies involving laboratory controls and electronic data integrity in current good manufacturing practice activities. The FDA placed the facility under import alerts and stated that regulatory restrictions could remain until the cited issues were corrected and compliance was confirmed.