1Documentation and records
The master production and control records are deficient in that they do not include a statement oftbeoretical yield and minimum, maximum.
Inspection Record
Ameridose, LLC — FDA 483 Findings
Inspectors Richard H. PentaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
The batch production and control records are deficient in that they do not include a statement of the actual yield and percentage of theoretical yield.
3Material and supplier control
Written procedures are lacking which describe in sufficient detail the identification, sampling, testing, approval, and rejection of components.
4Documentation and records
Batch production and control records do not include results of the inspection of the packaging and labeling area before and after use for each batch of drug product produced.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
