Tarmac Products, Inc.
Form 483 issued September 27, 2019 · Miami Gardens, Florida
- Inspection
- Sep 9 – Sep 27, 2019
- Investigators
- Jennifer L. Huntington· Karen M. Rodriguez
- Observations
- 17
- Pages
- 25
- FEI number
- 1025483
In short: On September 27, 2019, FDA issued a Form 483 with 17 observations to Tarmac Products, Inc. in Miami Gardens, Florida (FEI 1025483) after an inspection that ran Sep 9 – Sep 27, 2019. The investigators were Jennifer L. Huntington and Karen M. Rodriguez. Most observations concern production & process controls and laboratory controls.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
The written stability testing…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmTarmac Products, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tarmac Products, Inc.?
FDA listed 17 observations on this Form 483, mostly about production & process controls, laboratory controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Tarmac Products, Inc.?
Jennifer L. Huntington and Karen M. Rodriguez are named on this Form 483, for the inspection of Sep 9 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Tarmac Products, Inc. inspected by FDA?
The inspection ran Sep 9 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Tarmac Products, 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.