Company
United StatesPiramal Critical Care, Inc., Bethlehem, PA – FDA Inspections
Inspection records and compliance data for Piramal Critical Care, Inc. in Bethlehem, Pennsylvania. 9 FDA inspections on record, 3 Form 483s, last inspected September 27, 2023.
Company Profile
This profile covers Piramal Critical Care, Inc. based in Bethlehem, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 7
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected August 26, 2010. Last inspected September 27, 2023.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Scientifically sound laboratory controls2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2023 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1218865 |
| May 7, 2019 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1091231 |
| July 19, 2018 | Not classified | Medical Devices & Rad Health | 1136915 |
| September 22, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1030647 |
| October 31, 2014 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 904540 |
| July 26, 2013 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 842131 |
| April 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 778141 |
| August 12, 2011 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 739346 |
| August 26, 2010 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 680635 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Piramal Critical Care, Inc.
FEI Number
1000135935
Address
3950 Schelden Cir, Bethlehem, Pennsylvania 18017, United States
Country
United States
ID: 9cb01f72-bedf-48bc-acb6-d2d9933a3f0f