Class II · Moderate risk Completed
Sermorelin Acetate 1 MG/ML Injectable
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Completed
MIC/B12/L-Carn
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
MIC/B12 25/50/50/1 MG/ML Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
L-Carnitine 500 mg/mL Injectable
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
ClomiPRAMINE Hydrochloride Capsules
Reason Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class II · Moderate risk Terminated
Neomycin Sulfate Tablets
Reason CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I · High risk Terminated
PROPOFOL Injectable Emulsion
Reason Presence of particulate matter
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk Terminated
Triamcinolone Acetonide Cream USP
Reason CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk Terminated
Proton Armor
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk Terminated
Proton Armor
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk Ongoing
Colgate Whitening Mouthwash
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER…
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason cGMP Deviations: deviations leading to potential cross-contamination.
Class II · Moderate risk Terminated
PF-Labetalol HCl Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
PF-0.125% Bupivacaine HCl Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
Trisodium Citrate 0.5% Solution
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
PF-Neostigmine Methylsulfate Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class III · Low risk Ongoing
Timolol Maleate Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class II · Moderate risk Terminated
Corsair Personal Care 99X Instant Foam Hand Sanitizer
Reason CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.