Alan A Rivera, FDA Investigator

Alan A Rivera, who also appears on FDA documents as Alan Rivera, is an FDA investigator whose record on Atlas runs from April 2022 to April 2026: 40 inspections at 38 sites and 64 Form 483 observations. Nineteen of the 20 Form 483s in the published record are for human drug facilities; one is for an animal drug manufacturer.

Most of the work is in Puerto Rico. Nine of the 20 Form 483s went to facilities in San Juan, Gurabo, Caguas, Carolina, Juncos, Humacao and Manati, including Amgen Manufacturing in Juncos and Gasco Industrial in Gurabo, which received a 483 in both 2022 and 2023. Five went to Indian facilities, among them Amneal Pharmaceuticals in Palli, Concord Biotech and Stallion Laboratories in Ahmedabad, and OneSource Specialty Pharma in Bengaluru.

The forms are short: 3.2 observations on average, seven at most. The regulation cited most is 21 CFR 211.100(a), written production and process control procedures, followed by 211.192 investigations and 211.22(d) quality unit procedures. Alan Rivera most often inspects with Marian E Ramirez, who co-signed nine of the 20 forms, and Angelica M Hernandez, who co-signed six. For what a 483 is and what follows one, see what an FDA Form 483 is.