FDA Hits Allegiant Health for Lapses in Controls and Storage
The FDA faulted drugmaker Allegiant Health for neglecting multiple controls in procedures at its New York facility.
The Form 483 cites the drugmaker for multiple observations following an inspection between Oct. 25 and Nov. 2, 2016.
The investigators found the facility had inadequate controls for tablets, noting the firm did not perform accurate reviews and sign-offs on documentation.
Allegiant also failed to store drug products at an appropriate temperature and humidity, protecting the products’ identity, strength, quality and purity, the agency said.