Able Laboratories was a generic drugs manufacturer based in Cranbury New Jersey. During a FDA site inspection in 2005 the quality control laboratory at Able Laboratories.
1. Resampled, Re-injected or Reprocessed
Were found to have routinely resampled, re-injected or reprocessed samples of drug products during quality control (QC) testing when out of specification (OOS) results were obtained.
Able Laboratories failed to report any of these OOS results, which were replaced by results conforming to specification. This company also failed to maintain any records to explain the reprocessing or reinjection of samples that gave OOS results.
2. Failed to Document
Failed to document complete information associated with analytical testing, such as sample weights, chromatograms and data processing methods.
3. Manipulated Laboratory Records
Manipulated laboratory records by cutting and pasting chromatogram headers and changing the record of injection sequences.
4. Manipulated Sample Weights
Manipulated sample weights used to calculate assay results until a passing result was obtained, and the original sample weights were discarded.
5. Manipulated Chromatographic Data
Manipulated chromatographic data processing methods were changed until a processing method produced a passing result.
It is important to note that these activities only came to light on the examination of electronic records, and were not apparent from the signed paper records.