1Material and supplier control
The firm is not following their supplier qualification and audit procedures that require a audit of the supplier every two years.
Inspection Record
Schering-Plough Products, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The firm submission for Gentocin Solution, NADA # 38-292 dated December 18, 1996 included a Schering Plough’s guideline for HPLC impurity limits for Gentamicin Sulfate study.
3Other quality system
Your firm can not assure the processes used to manufacture finished pharmaceutical products can consistently produce product which meet their pre-determined specifications.
4Contamination control
Since February 1999 all stability testing ofbatches ofGentocin otic solution (Gentamicin Sulfate (3mg/ml) w/ Betamethasone Valerate (1mg/ml)) has revealed a contamination of the product in the form of an unknown peak-in the Betamethasone Valerate assay.
5Other quality system
The firm detected a “fourth spot” in the TLC identity test for Garamycin Cream, lot 9-HB-1, The firm’s: | tested one previous batch (5-HB-1) from its retain samples.
6Other quality system
The firm does not perform identification ofunknown degradation products and impurities for products that are listed under product quality review program.
7Other quality system
Loteiaaaiigg@aatofDiazoxide did not meet specifications for solubility in alkali.
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.
