MW ENCAP LIMITED
Form 483 issued December 14, 2018 · Livingston, United Kingdom
- Inspection
- Dec 10 – Dec 14, 2018
- Observations
- 2
- Pages
- 3
- FEI number
- 3005910213
In short: On December 14, 2018, FDA issued a Form 483 with 2 observations to MW ENCAP LIMITED in Livingston, United Kingdom (FEI 3005910213) after an inspection that ran Dec 10 – Dec 14, 2018. 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
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
When errors occurred or a production batch or any component of the batch, failed to meet…
This inspection in context
Questions about this 483
What did FDA find at MW ENCAP LIMITED?
FDA listed 2 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 MW ENCAP LIMITED inspected by FDA?
The inspection ran Dec 10 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
How do I get the full Form 483 for MW ENCAP LIMITED?
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.