3M receives 2-item 483; cleaning validation problems noted in EIR.(Human drugs)

Cleaning validation problems befell 3M's Northridge, CA, facility, although the observations were not included in the two-item 483 the company received.

According to the EIR, the Northridge facility makes prescription tablets, aerosols and transdermal patches. Investigator Kari Johansen from FDA's Irvine, CA, District Office, performed the inspection.

According to the EIR, Johansen reviewed cleaning validation procedures with the firm's product team lead. The document states: "I reviewed the QVAR Cleaning Validation Protocol and Report from December 1998, covering all the equipment used to manufacture QVAR. The rationale for allowable residues and cleaning components was documented, but the firm did not explain the equipment swab sampling points or describe the exact location."

The employee said he swabbed the worst-case points within the equipment, "which was determined by the engineers performing the cleaning validation," the FIR stated. "[The employee] said they were different in that the engineers, who knew the equipment best, were the same people who performed the cleaning validation."

Johansen also reviewed the firm's micronizer table. "The summary report showed that the micronizer table exceeded the allowable residual level," the FIR noted. "The firm's report considered the validation acceptable because the table was not considered in product contact," the FIR noted.