Quality Chemical Laboratories
Form 483 issued July 27, 2017 · Wilmington, North Carolina
- Inspection
- Jul 24 – Jul 27, 2017
- Observations
- 2
- Pages
- 6
- FEI number
- 3002323490
In short: On July 27, 2017, FDA issued a Form 483 with 2 observations to Quality Chemical Laboratories in Wilmington, North Carolina (FEI 3002323490) after an inspection that ran Jul 24 – Jul 27, 2017. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written production and process control procedures are not documented at…
This inspection in context
Questions about this 483
What did FDA find at Quality Chemical Laboratories?
FDA listed 2 observations on this Form 483, mostly about quality system and production. 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 Quality Chemical Laboratories inspected by FDA?
The inspection ran Jul 24 – Jul 27, 2017, and the Form 483 is dated July 27, 2017.
How do I get the full Form 483 for Quality Chemical Laboratories?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.