1Documentation and records
The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
Inspection Record
Complete Pharmacy and Medical Solutions, LLC dba Complete Pharmaceutics — FDA 483 Findings
Inspectors Jennifer L HuntingtonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
3Other quality system
Your firm compounds drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).
4Material and supplier control
Specific identification tests are not conducted on components that have been accepted based on the supplier's repo1t of analysis.
5Laboratory and QC controls
Testing and release of drng product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
6Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, stJ:ength, quality and purity at the time of use.
About this record
Extracted automatically from the document US FDA published on 2019-07-25. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
