Company
United StatesAcella Pharmaceuticals, LLC, Alpharetta, GA – FDA Inspections
Inspection records and compliance data for Acella Pharmaceuticals, LLC in Alpharetta, Georgia. 10 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected December 18, 2024.
Company Profile
This profile covers Acella Pharmaceuticals, LLC based in Alpharetta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 2
- VAI
- 6
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected August 18, 2009. Last inspected December 18, 2024.
Most cited issue areas
- Procedures not in writing, fully followed3 inspections
- Investigations of discrepancies, failures2 inspections
- Procedures to be written and followed2 inspections
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2024 | VAI | Human Drugs · Postmarketing Surveillance and Epidemiology: Human Drugs | 1232099 |
| February 10, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1197977 |
| September 17, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1152922 |
| January 7, 2020 | OAI | Human Drugs · Drug Quality Assurance | 1115488 |
| October 28, 2015 | VAI | Human Drugs · Unapproved and Misbranded Drugs | 947620 |
| September 10, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 897316 |
| October 31, 2013 | VAI | Human Drugs · Unapproved and Misbranded Drugs | 854221 |
| March 22, 2012 | VAI | Human Drugs · Drug Quality Assurance | 779795 |
| April 2, 2010 | VAI | Human Drugs · Drug Quality Assurance | 656389 |
| August 18, 2009 | NAI | Human Drugs · Drug Quality Assurance | 605230 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Acella Pharmaceuticals, LLC
FEI Number
3006691461
Address
1880 Mcfarland Pkwy Ste 110, Alpharetta, Georgia 30005, United States
Country
United States
ID: 95727716-8bc6-4b45-8f0b-2c018ea7f296