Kathy Whitney
General Manager
Accra-Pac, Inc. dba Voyant Beauty
1919 Superior Street
Elkhart , IN 46516-4707
United StatesFEI 1818911Issued Apr 20, 2023Division of Pharmaceutical Quality Operations III
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 1818911.
Violations3
Issue DateApr 20, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Accra-Pac, Inc. dba Voyant Beauty
Location
Kathy Whitney
General Manager
Accra-Pac, Inc. dba Voyant Beauty
1919 Superior Street
Elkhart , IN 46516-4707
United States
FEI Number
1818911
Country
United States
Issue Date
April 20, 2023
Issuing Office
Division of Pharmaceutical Quality Operations III
Product Type
Drugs
Status
Open
Summary
Accra-Pac, Inc. dba Voyant Beauty received a warning for manufacturing adulterated OTC topical aerosol drug products due to significant Current Good Manufacturing Practice (CGMP) violations. During an August-September 2022 inspection, the FDA found that the company failed to thoroughly investigate unexplained discrepancies and batch failures, particularly regarding benzene contamination at unacceptable levels in distributed products, indicating non-functioning quality assurance processes. The company manufactures both drug and cosmetic products using shared equipment for multiple customers, and the contamination discovery demonstrated that the facility's methods, controls, and facilities do not conform to CGMP requirements under 21 CFR parts 210 and 211.
Accra-Pac, Inc. dba Voyant Beauty FDA Warning Letter, April 20, 2023