Eosera Inc.
Form 483 issued March 20, 2026 · Fort Worth, Texas
- Inspection
- Mar 16 – Mar 20, 2026
- Investigators
- Margaret M. Annes· Oluwasefunmi Agbanigo
- Observations
- 10
- Pages
- 11
- FEI number
- 3013559620
In short: On March 20, 2026, FDA issued a Form 483 with 10 observations to Eosera Inc. in Fort Worth, Texas (FEI 3013559620) after an inspection that ran Mar 16 – Mar 20, 2026. The investigators were Margaret M. Annes and Oluwasefunmi Agbanigo. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
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 firmEosera Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eosera Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and materials. 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 Eosera Inc.?
Margaret M. Annes and Oluwasefunmi Agbanigo are named on this Form 483, for the inspection of Mar 16 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was Eosera Inc. inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for Eosera 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.