Internazionale Medico Scientifica 3/5/97 Mammography Systems
The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act, in that the methods used in, and the facilities or controls used for the manufacturing, packing, storage, and installation are not in conformance with the Good Manufacturing Practice (GMP) for Medical Devices Regulations, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820 as follows:
1. Failure to establish and implement specification control measures to assure that the design basis for the devices is correctly translated into approved specifications, as required by 21 CFR 820.100(a)(1). For example, the validation documentation was not available for the operation of the Giotto [purged word] and [purged word] units; including verification of the software functions with the mammography device.
Your response may be adequate if verified by documentation showing implementation. Your response noted that this deficiency would be completed by mid-February.
2. Failure to have adequate written procedures for testing components for conformance to specifications as required by 21 CFR 820.80(a). For example, the incoming inspection procedure ([purged word]) for components does not include testing procedures (or corresponding testing records) for EPROMS and circuit boards (w/EPROMS) used the Giotto [purged word] and [purged word] devices (e.g.: [purged word], [purged word] and [purged word] incoming components and EPROMS).
Your response may be adequate if verified by documentation showing implementation. Your response noted that a new procedure would be applied in March.
3a. Failure to establish and implement specification control measures to assure that the design basis for the devices is correctly translated into approved specifications, as required by 21 CFR 820.100(a)(1). For example, there are no records for the programming of EPROMS.
3b. Failure to maintain a record of component acceptance or rejection, as required by 21 CFR 820.80(a). For example, there are no records for the success/failure of the EPROM programming operation.
4. Failure of the device master record to be signed and dated by a designated individual(s), as required by 21 CFR 820.181. For example, the master and working copies of software for EPROMS used in Giotto [purged word] and [purged word] devices were not observed signed/dated as approved.
