Comment from Hybrid pharma
AnonymousOpposeIndividual
Summary: The commenter argues that the draft guidance fails to address specific concerns regarding inspector behavior, the lack of time limits for 483 closeouts and EIRs, and issues with the public release of warning letters. They express frustration that the document does not provide meaningful changes or protections for facilities.
Hello:
This guidance document did not address any concern about the facilities, at least for Hybrid.
This guidance document did not address any concern about the facilities, at least for Hybrid.
1 The behavior of the inspectors during inspection.
2. Writing anything and everything under the name of observation.
3. Even a compliant was made by the facility and not following through by the FDA.
4. With out releasing the 483 to the public releasing the warning letter without reviewing the 483. When asked the 483 response was missing
5. No time limit for the closeout for the 483.
6. No time limit for issuing the EIR.
....So on.
There is no change in this guidance document. This guidance documents are same as before. FDA write guidance documents and the facilities are supposed to follow that and the Inspectors and the FDA need not and they say it is a guidance document and we need not follow. If you want discuss more please contact me.