Woodbine Products Co Inc
Form 483 issued September 1, 2022 · Medina, Ohio
- Inspection
- Aug 29 – Sep 1, 2022
- Observations
- 8
- Pages
- 6
- FEI number
- 1519202
In short: On September 1, 2022, FDA issued a Form 483 with 8 observations to Woodbine Products Co Inc in Medina, Ohio (FEI 1519202) after an inspection that ran Aug 29 – Sep 1, 2022. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Questions about this 483
What did FDA find at Woodbine Products Co Inc?
FDA listed 8 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Woodbine Products Co Inc inspected by FDA?
The inspection ran Aug 29 – Sep 1, 2022, and the Form 483 is dated September 1, 2022.
How do I get the full Form 483 for Woodbine Products Co Inc?
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