FDA 483 - Ohm Laboratories, Inc. - August 12, 2009

This FDA Form 483 documents numerous deficiencies observed during an inspection. The facility failed to include distributed drug product quantities in annual reports and did not submit an NDA-Field Alert Report within three working days for a distributed batch failing specifications.

Significant quality system and manufacturing issues were identified: - Inadequate testing and record-keeping for drug product expiration dates. - Absence of written production and process control procedures to assure drug product identity, strength, quality, and purity. - Failure to document written production and process control procedures at the time of performance. - Incomplete investigations into batch failures, not extending to other potentially affected batches or products. - Unwritten and unfollowed responsibilities and procedures for the quality control unit. - Insufficient qualified personnel for processing drug products. - Lack of employee training in specific operations and GMP procedures. - Deficient complaint records lacking investigation findings. - Unspecified storage conditions in the written stability program for retained samples. - Undescribed sampling and testing plans for drug products in written procedures. - Unverified suitability of testing methods under actual use conditions. - Deficiently written or followed instrument calibration procedures. - Laboratory records lacking second-person review for accuracy and completeness. - Failure to maintain backup files for computer data and lack of backup procedures to ensure data integrity. - Inadequate controls over computer systems to restrict changes to authorized personnel. - Incomplete records for testing and standardization of laboratory