1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
You manufacture topical analgesic drug products, including “After Bite,” for the treatment of insect bite-related itching and burning in adults and children. Analytical records at your firm did not accurately represent the testing performed. For example, you injected samples on your high performance liquid chromatography (HPLC) system and did not include them in the laboratory records that were used by your Quality Unit (QU) for batch disposition decisions, including finished product release. Your laboratory management could not provide an adequate explanation for these unofficial injections to our investigator.
In addition, you failed to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. For example, your Infrared Spectrophotometer (IR) system did not have adequate access controls and was vulnerable to alteration or deletion of data by analysts. Laboratory employees shared a common log-in and password to access the system...
2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
You did not ensure your test methods were appropriate for their intended use. You lacked scientifically sound procedures for the testing of the active ingredients in your “After Bite” topical analgesic drug products and failed to adequately demonstrate the suitability of the testing method under actual conditions of use. These test methods were used to determine strength and identity of the active ingredient, sodium bicarbonate. Your firm’s method resulted in abnormal peaks, missing integration, and required the use of blank injections between samples to prevent carryover.
Furthermore, your firm attributed several system suitability failures (e.g., abnormal peaks and missed integrations) over a six-month period for the sodium bicarbonate assay testing to contamination, equipment malfunction, or incorrect HPLC process parameters. However, your firm failed to complete a comprehensive investigation into the source or sources of the deviations and include timely CAPA.
Your response is inadequate because you did not demonstrate that your analytical methods can consistently produce accurate and reliable results. Further, your response does not include details about improvements made to your investigation process.