FDA 483 - Omega & Delta Co., Inc. - May 06, 2022
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An FDA inspection of Omega & Delta Co., Inc. revealed multiple significant deficiencies in their drug manufacturing operations. The firm was cited for numerous violations of current Good Manufacturing Practices, including issues with equipment design, quality control, component identity verification, and discrepancy investigations. Additionally, observations noted problems with stability testing, facility maintenance, microbial control procedures, record-keeping, production controls, and employee training.
ID · 81c1badc-152a-476a-b1c4-46f37fd1fd0d