Buffalo Dental Manufacturing Co., Inc
Form 483 issued December 22, 2015 · Syosset, New York
- Inspection
- Dec 16 – Dec 22, 2015
- Investigator
- Jose O. Hernandez
- Observations
- 7
- Pages
- 4
- FEI number
- 2411056
In short: On December 22, 2015, FDA issued a Form 483 with 7 observations to Buffalo Dental Manufacturing Co., Inc in Syosset, New York (FEI 2411056) after an inspection that ran Dec 16 – Dec 22, 2015. The investigator was Jose O. Hernandez. Most observations concern records & documents and production & process controls; the most-cited regulation is 21 CFR 820.40 (document controls).
At a glance
Records & documents and production & process controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Document control procedures have not…
- 02
Records of changes to…
- 03
Procedures for identifying with a control number each unit, lot, or batch of implantable or life…
- 0421 CFR 820.18421 CFR 820
The device history record does not demonstrate that the device was manufactured in accordance with the…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmBuffalo Dental Manufacturing Co., Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.40
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buffalo Dental Manufacturing Co., Inc?
FDA listed 7 observations on this Form 483, mostly about records & documents, production & process controls and management controls. The most-cited regulation is 21 CFR 820.40 (document controls). The opening words of each observation are shown on this page.
Who inspected Buffalo Dental Manufacturing Co., Inc?
Jose O. Hernandez is named on this Form 483, for the inspection of Dec 16 – Dec 22, 2015. Each investigator has a profile showing what they cite most.
When was Buffalo Dental Manufacturing Co., Inc inspected by FDA?
The inspection ran Dec 16 – Dec 22, 2015, and the Form 483 is dated December 22, 2015.
How do I get the full Form 483 for Buffalo Dental Manufacturing Co., Inc?
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