483
Bullet Line LLCBullet Line LLC – FDA 483, Jun 10, 2022
Record Details
An FDA inspection of Bullet Line LLC, a drug packager and labeler in Florence, KY, revealed two significant observations. The firm lacked written procedures for preparing master production and control records and was unable to produce required batch records for hand sanitizer and lip balm. Additionally, routine calibration of mechanical equipment, specifically scales, was not performed according to a written program.
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ID · ea26641e-e019-4dbd-94e2-6dde95942d4c
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