American Injectables Inc.
Form 483 issued November 25, 2024 · Brooksville, Florida
- Inspection
- Nov 19 – Nov 25, 2024
- Investigator
- Marian E. Ramirez
- Observations
- 1
- Pages
- 2
- FEI number
- 3017511577
In short: On November 25, 2024, FDA issued a Form 483 with 1 observation to American Injectables Inc. in Brooksville, Florida (FEI 3017511577) after an inspection that ran Nov 19 – Nov 25, 2024. The investigator was Marian E. Ramirez. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 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
Aseptic processing areas are deficient regarding the system…
This inspection in context
Marian E. Ramirez
20 documents · 2016–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAmerican Injectables Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Injectables Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected American Injectables Inc.?
Marian E. Ramirez is named on this Form 483, for the inspection of Nov 19 – Nov 25, 2024. Each investigator has a profile showing what they cite most.
When was American Injectables Inc. inspected by FDA?
The inspection ran Nov 19 – Nov 25, 2024, and the Form 483 is dated November 25, 2024.
How do I get the full Form 483 for American Injectables 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.