Company
United StatesMcNeil Healthcare, LLC, Las Piedras, PR – FDA Inspections
Inspection records and compliance data for McNeil Healthcare, LLC in Las Piedras, Puerto Rico. 9 FDA inspections on record (2 OAI), 1 Form 483, last inspected September 20, 2023.
Company Profile
This profile covers McNeil Healthcare, LLC based in Las Piedras, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 2
- VAI
- 4
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected January 8, 2010. Last inspected September 20, 2023.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Procedures not in writing, fully followed2 inspections
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1219919 |
| March 31, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1141017 |
| June 21, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1060233 |
| March 31, 2015 | NAI | Human Drugs · Drug Quality Assurance | 921405 |
| August 27, 2013 | NAI | Human Drugs · Drug Quality Assurance | 847117 |
| October 26, 2011 | VAI | Human Drugs · Drug Quality Assurance | 751410 |
| November 2, 2010 | OAI | Human Drugs · Drug Quality Assurance | 695488 |
| February 3, 2010 | VAI | Human Drugs · Drug Quality Assurance | 643532 |
| January 8, 2010 | OAI | Human Drugs · Drug Quality Assurance | 638325 |
FDA documents
Form 483s (9)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
McNeil Healthcare, LLC
FEI Number
2650141
Address
State Road 183, Km 19.8 Bo. Montones 1, Las Piedras, Puerto Rico 00771, United States
Country
United States
ID: 5f388817-1e62-4133-bd19-17b205bff73c