Commenting on the ever-evolving Good Manufacturing Practice process, Israelsen said: “FDA inspectors are exchanging notes, increasing their collective knowledge base and, in my view, as the inspection process rolls on, you should expect more sophisticated and in-depth questions, investigations and an awareness of where common weak spots are likely to be found.”
483 reports detail FDA inspections. A scan of a selection of 483s performed by Israelsen reveals key areas where companies have fallen down. These include:
- Failure to prepare a written master manufacturing record for each unique formulation of a dietary supplement.
- Failure to establish component specifications for strength and composition.
- Failure to fill out material rejection/rework sheets.
- Failure to collect information regarding customer hospitalizations in in-bound complaints in order to determine if a MedWatch report needs to be submitted.
- Failure to establish a sampling plan for obtaining representative samples of components.
- No documentation to explain the rationale behind the testing performed and the specifications for various raw materials using USP methods intended for use in testing drug products but no evidence that these testing methods are suitable for use in testing DS ingredients and finished products.
- Indicating "PASS" instead of identifying specific ID test results.
- Non-use of metal detection equipment for liquid DS products.
- GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements.
- Failure to conduct appropriate tests or examinations or rely on a C of A to determine whether components met established specs.
- The firm's training records do not reflect training of personnel in DS GMPs.
- Batch records are general and printed out blank.
“There are many other observations, but the above are helpful insights as to what FDA inspectors are looking for and looking at,” Israelsen said.