483
Omega & Delta Co., Inc.FDA 483 - Omega & Delta Co., Inc. - March 20, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Omega & Delta Co., Inc., an OTC-Drug Manufacturer in Carolina, PR, received two observations during an FDA inspection. The firm failed to follow its own Standard Operating Procedure for timely annual product reviews and lacked established written procedures for rework and reprocessing of Over-the-Counter products. These findings indicate deficiencies in adhering to and establishing critical quality control procedures.
- Office
- San Juan District Office
- Person
Open in Dashboard
ID · 4f8f6255-90aa-426a-baee-5a32f90518d8