Claremore Compounding Center
Form 483 issued January 24, 2020 · Claremore, Oklahoma
- Inspection
- Jan 13 – Jan 24, 2020
- Investigator
- Margaret M. Annes
- Observations
- 3
- Pages
- 3
- FEI number
- 3004549371
In short: On January 24, 2020, FDA issued a Form 483 with 3 observations to Claremore Compounding Center in Claremore, Oklahoma (FEI 3004549371) after an inspection that ran Jan 13 – Jan 24, 2020. The investigator was Margaret M. Annes. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
- 02
There is no written testing program designed to assess the stability…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
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 firmClaremore Compounding Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Claremore Compounding Center?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Claremore Compounding Center?
Margaret M. Annes is named on this Form 483, for the inspection of Jan 13 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was Claremore Compounding Center inspected by FDA?
The inspection ran Jan 13 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Claremore Compounding Center?
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.