• Happy Holidays from Cafepharma! To allow its staff to spend holiday time with their families, the Cafepharma Message Boards will be switched to read-only from 6:00 PM Eastern time on Tuesday, December 24 until 10:00 PM Eastern time on Wednesday, December 25. During this time, all posts will be available for view. However, no one will be able to make new posts during this time.


Azmiro

Quote






anonymous said:
Who here thinks this product will suck in sales (another Adthyza launch) and we will all be laid off in the next 1-3 months?
Click to expand...
Let's see what the FDA WARNING LETTER says:
"Your firm’s investigations into unexplained discrepancies were inadequate. Your quality unit (QU) failed to thoroughly investigate all finished product batches and components associated with unexplained discrepancies. For example:

Your QU did not investigate numerous complaints involving crystallization of two (b)(4) Injection (b)(4) mg/mL batches. Your firm received approximately 86 complaints of crystallization within the first two months of distribution from early December 2022 to February 2023. Your QU did not evaluate this adverse trend until our inspection was initiated. A Field Alert Report was submitted during the inspection and the two batches were recalled before the conclusion of our inspection."
 












anonymous said:
Let's see what the FDA WARNING LETTER says:
"Your firm’s investigations into unexplained discrepancies were inadequate. Your quality unit (QU) failed to thoroughly investigate all finished product batches and components associated with unexplained discrepancies. For example:

Your QU did not investigate numerous complaints involving crystallization of two (b)(4) Injection (b)(4) mg/mL batches. Your firm received approximately 86 complaints of crystallization within the first two months of distribution from early December 2022 to February 2023. Your QU did not evaluate this adverse trend until our inspection was initiated. A Field Alert Report was submitted during the inspection and the two batches were recalled before the conclusion of our inspection."
Click to expand...
Are you talking about the first kit’s warning?
 






anonymous said:
Are you talking about the first kit’s warning?
Click to expand...
Beyond that...

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP regulations, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
...Upon receiving a consumer complaint regarding the potential presence of lead in two batches of (b)(4) mg/mL, (b)(4)-ounce (b)(4), your subsequent investigation focused solely on one of the two batches. Notably, a third batch, utilizing the same (b)(4) component as one of the complaint batches, was not included as part of your investigation. Additionally, your firm stated during our inspection that no testing was conducted to investigate...
 






anonymous said:
Beyond that...

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP regulations, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
...Upon receiving a consumer complaint regarding the potential presence of lead in two batches of (b)(4) mg/mL, (b)(4)-ounce (b)(4), your subsequent investigation focused solely on one of the two batches. Notably, a third batch, utilizing the same (b)(4) component as one of the complaint batches, was not included as part of your investigation. Additionally, your firm stated during our inspection that no testing was conducted to investigate...
Click to expand...
Why would they approve it to market?
 
















































how has the feedback been in offices? Patients inject themselves at our large practice .. only one strength?.. which wholesalers can we use for buy and bill.. (they have not told us) It isn’t really that unique, rep…
 












Betting on Azmiro being a 1-3 quarter product. Takes one call to cover everything. Just like Konvomep. Get the info out, move on, see what continues to trickle in from adopters.
 












Top Bottom
Back
Quote