Armand Products Company, Inc
Form 483 issued October 1, 2019 · Muscle Shoals, Alabama
- Inspection
- Sep 10 – Oct 1, 2019
- Investigator
- Samantha J. Bradley
- Observations
- 1
- Pages
- 2
- FEI number
- 1053120
In short: On October 1, 2019, FDA issued a Form 483 with 1 observation to Armand Products Company, Inc in Muscle Shoals, Alabama (FEI 1053120) after an inspection that ran Sep 10 – Oct 1, 2019. The investigator was Samantha J. Bradley. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.65 (equipment construction).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.65 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The system used in the production of a drug component is not appropriately designed, constructed, and…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
The firmArmand Products Company, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.65
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Armand Products Company, Inc?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.65 (equipment construction). The opening words of each observation are shown on this page.
Who inspected Armand Products Company, Inc?
Samantha J. Bradley is named on this Form 483, for the inspection of Sep 10 – Oct 1, 2019. Each investigator has a profile showing what they cite most.
When was Armand Products Company, Inc inspected by FDA?
The inspection ran Sep 10 – Oct 1, 2019, and the Form 483 is dated October 1, 2019.
How do I get the full Form 483 for Armand Products Company, 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.