Company
United StatesRobert Busse & Co., Inc., Hauppauge, NY – FDA Inspections
Inspection records and compliance data for Robert Busse & Co., Inc. in Hauppauge, New York. 6 FDA inspections on record, 2 Form 483s, last inspected April 13, 2018.
Company Profile
This profile covers Robert Busse & Co., Inc. based in Hauppauge, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected November 7, 2008. Last inspected April 13, 2018.
Most cited issue areas
- Environmental control Lack of or inadequate procedures2 inspections
- Backup data not assured as exact and complete1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 13, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1048678 |
| October 19, 2016 | NAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 993771 |
| February 27, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 918565 |
| October 10, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 802601 |
| April 11, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 719303 |
| November 7, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 546561 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Robert Busse & Co., Inc.
FEI Number
2433012
Address
75 Arkay Dr, Hauppauge, New York 11788, United States
Country
United States
ID: 465529b3-d629-44df-860f-10ecdfd3da94