1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).Always empty the recycle bin!
Your firm lacks basic laboratory controls to prevent changes to paper and electronic records for your over-the-counter (OTC) drug products. You were not able to provide analytical test data for three batches of [redacted] spray and one batch of [redacted]. We found that you created certificates of analysis (COA) for these four batches before they were manufactured and tested.
When questioned, your firm acknowledged falsifying the analytical test results on the COA you used to support release and distribution of [redacted] spray and [redacted] drug products to the United States.
In addition, we found three electronic data files in the electronic recycle bin of the stand-alone HPLC system you used to test finished drug product [redacted] spray. Because this instrument lacks back-up and audit trail capabilities, we could not determine how frequently test data obtained prior to “official” batch testing was discarded. You were unable to explain why these electronic files were deleted.
Wednesday, March 7, 2018
Warning Letter of the Week: PC desktop recycle bin edition
A friendly note to the general manager of Zhejiang Ludao Technology Co., Ltd. from the Center for Drug Evaluation and Research: