OR WAIT null SECS
The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.
Huntsville, AL (Feb. 1)-The US Food and Drug Administration issued generics manufacturer Vintage Pharmaceuticals a Warning Letter following inspections conducted from July through Aug. 2007 that found microbial contamination and failures in testing and documentation procedures. The company operates under the name Qualitest Pharmaceuticals and is reportedly the eighth largest distributor of generic drugs in the United States.
The letter cites violations of current good manufacturing practices (CGMPs) in the company’s “failure to adequately investigate evidence of microbiological contamination and failure to maintain a complete record of data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation [21 CFR 211.192 and 211.194(a)(4)].”
FDA investigators also point to the company’s failure to properly document the results of required microbial tests on media, including identification testing of observed growth. The letter states “It is unclear why there would not have been a sufficient amount of the original sample remaining to obtain a new isolate, which we believe would have increased the chance of identifying the microorganism. Additionally, in contrast to your investigation report, during the inspection, Vintage personnel told our investigators retesting was not conducted on the original sample because the isolate from the original sample was lost.”
The letter recognizes the company’s failure to follow standard operating procedures but on several items does not agree with the company’s response to the 483 observation and notes authorization violations: “It is not appropriate for anyone other than the analyst who conducted the test and entered it into the laboratory notebook to sign and date the entry. It also is not appropriate to rely on handwriting analysis to determine who performed the work. The CGMP regulations in 21 CFR 211.194(a)(7) require laboratory records to contain the signature and date of the person who performs each test.
This is the second Warning Letter for the company in one year. The previous letter addressed concerns about the company’s marketing for one of its products.