Kingkey MBC Life Technology Group co., LTD.
Form 483 issued March 8, 2019 · Shantou City, China
- Observations
- 4
- Pages
- 2
- FEI number
- 3004609163
In short: On March 8, 2019, FDA issued a Form 483 with 4 observations to Kingkey MBC Life Technology Group co., LTD. in Shantou City, Guangdong (FEI 3004609163). Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.101 (charge-in of components).
At a glance
Production and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.101 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 02
Each component is not added by one person and verified…
- 03
Each container of component dispensed to manufacturing is not examined by a second person to ensure…
- 04
Routine calibration of electronic equipment is not performed according to a written program designed…
This inspection in context
Questions about this 483
What did FDA find at Kingkey MBC Life Technology Group co., LTD.?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.101 (charge-in of components). The opening words of each observation are shown on this page.
When was Kingkey MBC Life Technology Group co., LTD. inspected by FDA?
This Form 483 is dated March 8, 2019.
How do I get the full Form 483 for Kingkey MBC Life Technology Group co., LTD.?
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