1Aseptic processing and sterility assurance
The drug product label did not include a list of active ingredients identified by established name. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection. Further, the investigator collected evidence of the following deficiencies with your facility’s container labels…
2Labeling and packaging
The drug product label did not include the dosage form. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL and Fentanyl Citrate 2mcg/mL (100mcg/50mL)/Ropivacaine HCl 0.15% (1.5mg/mL) (75mg/50mL).
3Aseptic processing and sterility assurance
The drug product label did not include the established name of the drug. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection.
4Equipment and facility
Your firm produced drug products while construction was underway without adequate controls to prevent contamination of the product environment and products. The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example…
5Aseptic processing and sterility assurance
The container from which the individual units of the drug are removed for dispensing or for administration did not include directions for use, including, as appropriate, dosage and administration. Examples include: Epinephrine (1mg/mL), Sterile Solution for Injection; Phenol Injection 6% (60 mg/mL), in Sterile Water for Injection, 10 mL in Multi-Dose Vial; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Dexamethasone Sodium Phosphate 10 mg/mL Solution for Injection, 2 mL in Multi-Dose Vial.
6Equipment and facility
Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)).
7Aseptic processing and sterility assurance
You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.
8Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
9Aseptic processing and sterility assurance
The container from which the individual units of the drug are removed for dispensing or for administration did not include a list of active ingredients identified by established name. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection. Because your compounded drug products have not met…
10Aseptic processing and sterility assurance
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR…
