Eosera Inc.
Form 483 issued January 17, 2020 · Fort Worth, Texas
- Inspection
- Jan 13 – Jan 17, 2020
- Investigators
- Patty P. Kaewussdangkul· Shanna N. Purdy
- Observations
- 5
- Pages
- 3
- FEI number
- 3013559620
In short: On January 17, 2020, FDA issued a Form 483 with 5 observations to Eosera Inc. in Fort Worth, Texas (FEI 3013559620) after an inspection that ran Jan 13 – Jan 17, 2020. The investigators were Patty P. Kaewussdangkul and Shanna N. Purdy. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Laboratory controls and materials account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Drug products failing to meet established…
- 03
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 04
Results of stability testing are not used…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eosera Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, 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 Eosera Inc.?
Patty P. Kaewussdangkul and Shanna N. Purdy are named on this Form 483, for the inspection of Jan 13 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Eosera Inc. inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for Eosera Inc.?
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