Continental Manufacturing Chemist
Form 483 issued July 30, 2019 · Huxley, Iowa
- Inspection
- Jul 22 – Jul 30, 2019
- Observations
- 5
- Pages
- 7
- FEI number
- 3014469173
In short: On July 30, 2019, FDA issued a Form 483 with 5 observations to Continental Manufacturing Chemist in Huxley, Iowa (FEI 3014469173) after an inspection that ran Jul 22 – Jul 30, 2019. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Failure to maintain a backup file of data entered into the…
- 04
Routine calibration, inspection and checking of automatic and electronic equipment is not performed according to a…
This inspection in context
Questions about this 483
What did FDA find at Continental Manufacturing Chemist?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Continental Manufacturing Chemist inspected by FDA?
The inspection ran Jul 22 – Jul 30, 2019, and the Form 483 is dated July 30, 2019.
How do I get the full Form 483 for Continental Manufacturing Chemist?
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