Dixon Investments Inc.
Form 483 issued March 22, 2019 · Orchard Hill, Georgia
- Inspection
- Mar 19 – Mar 22, 2019
- Investigator
- Susan O. Oladeji
- Observations
- 7
- Pages
- 5
- FEI number
- 1037559
In short: On March 22, 2019, FDA issued a Form 483 with 7 observations to Dixon Investments Inc. in Orchard Hill, Georgia (FEI 1037559) after an inspection that ran Mar 19 – Mar 22, 2019. The investigator was Susan O. Oladeji. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmDixon Investments Inc. history
All 2 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 Dixon Investments Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Dixon Investments Inc.?
Susan O. Oladeji is named on this Form 483, for the inspection of Mar 19 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was Dixon Investments Inc. inspected by FDA?
The inspection ran Mar 19 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
How do I get the full Form 483 for Dixon Investments Inc.?
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