Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
NVision Laser Eye Centers Newport Beach, CA (11/2). Inspected 6/29-7/17. Clinical study violations: The firm failed to submit an IND for the conduct of a clinical investigation with an investigational new drug. NVision studied the efficacy of 0.1% and 0.25% riboflavin ophthalmic solutions, in combination with ultraviolet-A-induced cross-linking of corneal collagen for treating keratoconus or ectasia. FDA says that because the ophthalmic solution was intended for treating keratoconus or ectasia, the riboflavin ophthalmic solution meets the definition of a drug under the FD&C Act and the firm should have filed an IND to administer it. The firm also failed to ensure proper monitoring of the clinical investigations. Additionally, it failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects, etc. (study of riboflavin ophthalmic solutions in combination with ultraviolet-A-induced cross-linking of corneal collagen for treating keratoconus or ectasia); 21 CFR 312.2(a), 312.20(a), (b) and 312.40(a), (b), 312.50 and 312.56(a), 312.62(a)
One Way Drug, LLC dba Partell Specialty Pharmacy Las Vegas, NV (7/22). Inspected 5/21-30/14. CGMP violations, adulterated, misbranded: Investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Sterile drug products were prepared, packed, or held under insanitary conditions. For example, investigators observed an operator (purged) stoppering vials with gloved hands on a table that is only partially separated (by curtains) from a less clean area, and processing sterile drug products with exposed skin on (purged) face. Also, an operator was observed placing bulk drug product containers from the ISO-7 cleanroom into the ISO-5 area without sanitization. The 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, etc. (drug products); FDCA 502(f)(1), 505(a), 501(a)(2)(A), 21 CFR 211.113(b), 211.42(c)(10)(iv)(v), 211.28(a), 211.42(b), 211.94(c), 211.167(a), 211.166(a)
WalkMed Infusion, LLC Centennial, CO (11/2). Inspected 5/18-6/11. QSR deviations, adulterated: The firm failed to conduct adequate investigations for complaints related to issues where its devices may have failed to perform to their specifications. It continued to refer to Corrective Action Report (CAR)(purged) to explain why it did not conduct an additional investigation of the cited complaints, but the CAR is inadequate as it does not include as part of the complaint investigation an assessment for the adequacy of the testing equipment used, the (purged) design, or the overall testing parameters. The firm also failed to establish and maintain procedures for validating the device software for the Triton FP infusion pumps to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, etc. (electronic infusion pumps (ambulatory and pole mounted), reservoir bags, and administration sets); FDCA 501(h), 501(f)(1)(B), 502(o), 21 CFR 820.198(c), 820.100(a)(1), 820.90(a), 820.30(g), 820.30(f)&(g), 820.72(b), 803