1Other quality system
The--- (b)l4l dmg substance manufacturing process is not adequately controlled to ensure that the in- process inte1mediates did not become contaminated to assure product quality.
Inspection Record
Dr. Reddy's Laboratories Ltd., Biologics — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The CbT drng substance manufacturing areas are not under control for mold.
3Other quality system
6}(' The post PPQ ___ diug substa!}ce manufacturing process is not consistent.
4Cleaning validation
Your fnm failed to provide adequate assurance that your cleaning validation procedures are effective to prevent contamination of (bT product-contact process equipment in (bf<4l Specifically, a.
5Other quality system
The viral control strat::7 at Dr.
6Deviation, CAPA, and investigation
The investigations and co1Tective actions due to visual inspection limit excursion ai·e inadequate to addi·ess defective,__ Chm diug product trends.
7Other quality system
The documentation and assessment of potential risks and abnoimalities during GMP manufacturing are deficient.
8Aseptic processing and sterility assurance
The WCl sterilization validation of direct and indirect sterile product-contact items is not sufficient to demonstrate sterility assurance: c.
9Other quality system
Cb>1 4 chug product manufacturing process is not under adequate control.
About this record
Extracted automatically from the document US FDA published on 2025-03-06. 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.
