Tarmac Products, Inc.
Form 483 issued July 22, 2022 · Miami Gardens, Florida
- Inspection
- Jul 11 – Jul 22, 2022
- Investigators
- Damaris Y. Hernandez· Joanne E. King
- Observations
- 5
- Pages
- 5
- FEI number
- 1025483
In short: On July 22, 2022, FDA issued a Form 483 with 5 observations to Tarmac Products, Inc. in Miami Gardens, Florida (FEI 1025483) after an inspection that ran Jul 11 – Jul 22, 2022. The investigators were Damaris Y. Hernandez and Joanne E. King. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, specifications…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tarmac Products, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Tarmac Products, Inc.?
Damaris Y. Hernandez and Joanne E. King are named on this Form 483, for the inspection of Jul 11 – Jul 22, 2022. Each investigator has a profile showing what they cite most.
When was Tarmac Products, Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 22, 2022, and the Form 483 is dated July 22, 2022.
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.