Mr. José Antonio Díaz Barriga Ahued
President & CEO
Dibar Nutricional S. de R.L. de C.V.
Eucalipto No. 20, Col. Puerto de Buenavista
58302 Morelia , Mich.
MexicoFEI 3012040386Issued Mar 10, 2021Center for Drug Evaluation and Research
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012040386.
Violations5
Issue DateMar 10, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Dibar Nutricional S. de R.L. de C.V.
Location
Mr. José Antonio Díaz Barriga Ahued
President & CEO
Dibar Nutricional S. de R.L. de C.V.
Eucalipto No. 20, Col. Puerto de Buenavista
58302 Morelia , Mich.
Mexico
FEI Number
3012040386
Country
Mexico
Issue Date
March 10, 2021
Issuing Office
Center for Drug Evaluation and Research
Product Type
Drugs
Status
Open
Summary
Dibar Nutricional S. de R.L. de C.V., a Mexican manufacturer of over-the-counter drug products, failed to comply with current good manufacturing practices (CGMP) for finished pharmaceuticals, resulting in adulterated drug products. The company did not conduct adequate identity testing of incoming component ingredients before release and distribution to the United States, relying instead on random sampling and sensory evaluation rather than required chemical and microbiological testing for each lot. This violation of 21 CFR 211.84(d)(1) meant the firm could not verify the identity of each component used in its drug products.
Dibar Nutricional S. de R.L. de C.V. FDA Warning Letter, March 10, 2021
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