Triad Rx, Inc.
Form 483 issued July 21, 2017 · Daphne, Alabama
- Inspection
- Jul 17 – Jul 21, 2017
- Investigator
- Brandon C. Heitmeier
- Observations
- 9
- Pages
- 3
- FEI number
- 3013497126
In short: On July 21, 2017, FDA issued a Form 483 with 9 observations to Triad Rx, Inc. in Daphne, Alabama (FEI 3013497126) after an inspection that ran Jul 17 – Jul 21, 2017. The investigator was Brandon C. Heitmeier. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
8 of 9 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (8×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning pads or wipes used in the ISO 5…
- 02
The ISO-classified areas have difficult to clean, particle-generating, or visibly…
- 03
Inadequately or un-protected product intended to be sterile was observed to be exposed to lower than…
- 04
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with…
This inspection in context
Brandon C. Heitmeier
12 documents · 2009–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmTriad Rx, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triad Rx, Inc.?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Triad Rx, Inc.?
Brandon C. Heitmeier is named on this Form 483, for the inspection of Jul 17 – Jul 21, 2017. Each investigator has a profile showing what they cite most.
When was Triad Rx, Inc. inspected by FDA?
The inspection ran Jul 17 – Jul 21, 2017, and the Form 483 is dated July 21, 2017.
How do I get the full Form 483 for Triad Rx, 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.