Delta Pharma, Inc.
Form 483 issued April 12, 2024 · Ripl ey, Mississippi
- Inspection
- Apr 9 – Apr 12, 2024
- Investigator
- Margaret M. Annes
- Observations
- 3
- Pages
- 3
- FEI number
- 3004034796
In short: On April 12, 2024, FDA issued a Form 483 with 3 observations to Delta Pharma, Inc. in Ripl ey, Mississippi (FEI 3004034796) after an inspection that ran Apr 9 – Apr 12, 2024. The investigator was Margaret M. Annes. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (2×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted…
- 02
Written procedures are not followed for the sampling…
- 03
Representative samples are not taken of each shipment of each lot of components for…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmDelta Pharma, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delta Pharma, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Delta Pharma, Inc.?
Margaret M. Annes is named on this Form 483, for the inspection of Apr 9 – Apr 12, 2024. Each investigator has a profile showing what they cite most.
When was Delta Pharma, Inc. inspected by FDA?
The inspection ran Apr 9 – Apr 12, 2024, and the Form 483 is dated April 12, 2024.
How do I get the full Form 483 for Delta Pharma, 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.