Washington Homeopathic's déjà vu
Repeated offenses have led the FDA to question Washington Homeopathic Products' commitment to CGMP abilities after an inspection conducted in late March through early April. At issue are a recent company investigation of bad product batches and six CGMP deviations cited in a letter from two years prior.
The regulator found during the inspection of the company's Berkeley Springs, WV, facility that Washington Homeopathic had skimped on its investigation of a batch failure and hadn't extended the investigation to other potentially affected drug products. The FDA noted in a warning letter that a product sample manufactured July 23, 2008, failed microbiological testing July 30. A second sample failed August 1 and a third failed August 5. The fourth sample passed August 10 and the company shipped the product August 12.
Although the record contains relevant details, the FDA said the company needed to explain why it conducted no investigation into the failed batch. "Please explain your firm's scientific rationale for the testing scheme used, including why the first three tests were disregarded."
The FDA says in the letter that it also had observed in November 2007 "significant problems with the control of your manufacturing facilities." The regulator goes on to detail six additional observations repeated from the 2007 inspection:
- Failure to identify and investigate products and lots manufactured in proximity to the location where vials were found to contain broken glass; Failure to reject lots of components out of spec for identity, strength, quality and purity;
- Failure to withhold from use each lot of components until the lot has been sampled, tested, examined, and released by quality control;
- Failure to establish written procedures for production and process control that ensure drugs have the identity, strength, quality and purity stated;
- Failure to identify process parameters, write validation protocols, and show that drug product performance is consistent and reproducible from batch to batch; and
- Failure to have a written assessment of stability of homeopathic drug products.