Class I - Dangerous
cGMP deviations
KVK Tech
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I - Dangerous
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class I - Dangerous
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class I - Dangerous
Presence of Foreign Substance; Fiber particles.
Class I - Dangerous
Labeling: Wrong bar code
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class I - Dangerous
Discoloration: presence of scuffing marks on tablets.
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class I - Dangerous
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.