FDA-Rx – GMP Draft Guidance for 503B-AHA says <797> and <800> need to be delayed-several new 483s
Thrifty White Drug #762 of Minneapolis, MN was issued a 483 on 9/21/2018 at the end of its first ever FDA Inspection. Six Observations were recorded by two investigators who were on site for five days and who typed the entity as a Producer of Sterile and Non-sterile Drug Products. The Observations were those typically cited: …