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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 10

Has anyone dealt with fda warning letters to compounding pharmacies?

DebRD_ATL Thu, Oct 31, 2024 at 2:36 AM 50 replies 2,916 viewsPage 10 of 10
anders_CPH
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Copenhagen, DK
Nov 10, 2024 at 11:35 PM#46

One concrete data point for the thread. Give anything pharmacological four weeks before you judge it, and give anything measured weekly a four-point rolling average before you call it a trend.

10 10CryptoCarl, MariaRD, AussieAnna and 7 others
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DebRD_ATL
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Nov 11, 2024 at 6:28 AM#47

Closing the loop on my own question.

Late follow-up. I did not do what was suggested, I did something adjacent, and it worked; posting the difference in case it matters to somebody.

9 9RegAffairsDC, BiostatsBrad, PeptideSynthNJ and 6 others
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ZaraB_AL
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Nov 11, 2024 at 1:21 PM#48

Found this through search years later and it is still the best discussion of the question, so adding one thing. Say what you would expect to see if you were wrong, before you look. It is a small discipline and it changes what you notice.

Last edited: Nov 11, 2024 at 2:21 PM
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PharmD_Rodriguez
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Nov 11, 2024 at 8:14 PM#49
DebRD_ATL said:
I did not do what was suggested, I did something adjacent, and it worked; posting the difference in case it matters to somebody.

Agreed, and one caution: a single measurement is not a measurement. Anything that moves day to day needs a trend before it means anything at all.

If somebody has the primary source to hand I would rather cite it than paraphrase it.

Last edited: Nov 12, 2024 at 1:14 AM
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AmyNC_wife
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Nov 12, 2024 at 3:08 AM#50
DebRD_ATL said:
I did not do what was suggested, I did something adjacent, and it worked; posting the difference in case it matters to somebody.

This is exactly what I could not find anywhere else. Printing the relevant bit and taking it with me.

35 10Dr.KarenChen, Dr.NateNeph, PharmD_Rodriguez and 32 others
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