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Pharmaceuticals / Submissions and Approvals

Oklahoma OTC Manufacturer Cited for Multiple Violations

April 8, 2019
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The FDA hit OTC drug manufacturer Tomco-Harwel Industries with an extensive Form 483 for numerous violations at its Tulsa, Oklahoma facility.

The agency’s Nov. 19-26, 2018 inspection of the antibacterial soap manufacturer revealed that the facility had no quality unit.

The investigator also found the facility lacked batch records and failed to place lot numbers on its finished products. The firm also failed to validate the manufacturing process and did not test to ensure products had the required identity, strength, quality and purity.

The facility had no written procedures for cleaning and maintenance of equipment, and it did not keep records of cleaning, maintenance and use, even though mixing tanks were used for multiple purposes. The investigator observed rust, peeling paint and thick residue on equipment used in the manufacturing process. The facility also failed to routinely calibrate mechanical and electronic equipment to assure proper performance.

The agency also noted problems with laboratory controls, including a lack of stability studies to justify the “Best By” dates placed on the products. The dates were based on when the label was printed “and not necessarily on the date that the product was manufactured,” the FDA said.

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