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ForumsVerified VendorsSwiss Chems got an FDA warning letter — January 2024 Page 2

Swiss Chems got an FDA warning letter — January 2024

bbq_ray_KC Sun, Aug 4, 2024 at 12:38 PM 11 replies 1,821 viewsPage 2 of 3
JennaRN
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Aug 4, 2024 at 2:24 PM#6
Dr.MetabolicMD said:
The pattern that distinguishes a bad batch from an exit is behaviour rather than product.

I disagree that testing history is decisive. It tells you what a supplier did when they were being watched. Continuity of behaviour under stress — a late shipment, a failed test, a complaint — is more predictive than any run of good results.

Last edited: Aug 4, 2024 at 3:24 PM
25 20Dr.KarenChen, Dr.NateNeph, PharmD_Rodriguez and 22 others
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anders_CPH
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Aug 4, 2024 at 3:05 PM#7
bbq_ray_KC said:
Eight months with one supplier, then a change in how they communicate that I noticed before I noticed anything about the product.

Shipping damage protocol for vendor vetting orders: if your package arrives with visible damage, temperature excursion, or broken vials:

  • Photograph EVERYTHING before discarding packaging
  • Note the temperature of the cold pack (liquid = possibly too warm)
  • Contact the vendor within 24 hours with photos
  • Request a replacement shipment or refund
  • Do NOT use potentially compromised medication

Reputable vendors will replace damaged shipments without argument. If they push back, that's a red flag about the vendor.

Last edited: Aug 4, 2024 at 7:05 PM
24 19MariaRD, AussieAnna, BethLabQueen and 21 others
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sarah_TO
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Aug 4, 2024 at 3:46 PM#8
JennaRN said:
I disagree that testing history is decisive.

Adding the part of the answer the thread has not reached. The mechanism and the magnitude are separate questions. Agreeing that something happens says nothing about whether it happens enough to act on.

23 18GraceAZ_72, carl_compliance, DanielChem_CHI and 20 others
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oliver_london
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Aug 4, 2024 at 4:27 PM#9

One thing that is still open after PeptideSynthNJ’s answer:

How people are distinguishing a supplier having a bad batch from a supplier on the way out?

Last edited: Aug 4, 2024 at 5:27 PM
22 17jason_paloalto, Dr.LeslieOBGYN, MikeNYC_runner and 19 others
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bbq_ray_KC
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Aug 4, 2024 at 7:43 PM#10

Closing the loop on my own question.

Went back through my own correspondence with an earlier supplier and the warning signs were all there in the replies, weeks before the quality changed. I was reading the product and not the behaviour.

20 18SaraMom3, Dr.MetabolicMD, RetaRick_CA and 17 others
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