Company
United StatesAdvance Pharmaceutical Inc, Holtsville, NY – FDA Inspections
Inspection records and compliance data for Advance Pharmaceutical Inc in Holtsville, New York. 12 FDA inspections on record (2 OAI), 3 Form 483s, last inspected February 27, 2025.
Company Profile
This profile covers Advance Pharmaceutical Inc based in Holtsville, New York, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 2
- VAI
- 8
- NAI
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected September 17, 2009. Last inspected February 27, 2025.
Most cited issue areas
- Procedures not in writing, fully followed7 inspections
- Absence of Written Procedures5 inspections
- Scientifically sound laboratory controls5 inspections
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1262179 |
| December 13, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1074294 |
| July 6, 2017 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1017139 |
| December 2, 2015 | OAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 953151 |
| March 6, 2015 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 923025 |
| December 19, 2013 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 859634 |
| July 2, 2013 | OAI | Human Drugs · Drug Quality Assurance | 841046 |
| January 11, 2013 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 813599 |
| December 9, 2011 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 756490 |
| February 14, 2011 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 709608 |
| April 15, 2010 | NAI | Human Drugs · Drug Quality Assurance | 659293 |
| September 17, 2009 | NAI | Human Drugs · Drug Quality Assurance | 614122 |
FDA documents
Form 483s (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Advance Pharmaceutical Inc
FEI Number
2434807
Address
895 Waverly Ave, Holtsville, New York 11742, United States
Country
United States
ID: a4ab6207-4e8b-464a-94b8-36c959425ac1