Areas cited
Other quality systemMaterial and supplier controlDeviation, CAPA, and investigationStability and storageRegulatory reporting and change controlAseptic processing and sterility assuranceValidation and qualificationEquipment and facilityLaboratory and QC controlsContamination control
Published inspection documents
2024-01-17
US FDA
8 findingsOther quality system · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility Failure to implement, in a timely manner, the new HPLC methods for assay and 3 Chromatographic impurities of Theophylline API and finished product.
2024-01-17
US FDA
7 findingsMaterial and supplier control · Regulatory reporting and change control · Other quality system · Contamination control The firm is not following their supplier qualification and audit procedures that require a audit of the supplier every two years.
2024-01-17
US FDA
11 findingsValidation and qualification · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Material and supplier control You have not developed validation/qualification master plans encompassing process, cleaning, computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999.
2024-01-17
US FDA
9 findingsOther quality system · Material and supplier control · Stability and storage · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance On this same page it discusses the out of guideline results for lots 1-AHU-3 and 1- AHU-4.
About this page
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.
What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
