Tetracore, Inc
Form 483 issued December 6, 2019 · Rockville, Maryland
- Inspection
- Dec 3 – Dec 6, 2019
- Investigator
- Jude C. Dike
- Observations
- 5
- Pages
- 6
- FEI number
- 3003517954
In short: On December 6, 2019, FDA issued a Form 483 with 5 observations to Tetracore, Inc in Rockville, Maryland (FEI 3003517954) after an inspection that ran Dec 3 – Dec 6, 2019. The investigator was Jude C. Dike. Most observations concern management controls and production & process controls.
At a glance
Management controls and production & process controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at…
- 02
Equi pm nt used in the manufac turing process has not been appropriately installed to facilitate…
- 03
Risk analysis was not…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmTetracore, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tetracore, Inc?
FDA listed 5 observations on this Form 483, mostly about management controls, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Tetracore, Inc?
Jude C. Dike is named on this Form 483, for the inspection of Dec 3 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Tetracore, Inc inspected by FDA?
The inspection ran Dec 3 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
How do I get the full Form 483 for Tetracore, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.