Hubei Meikai Chemical Co., Ltd.
Form 483 issued July 10, 2014 · Huanggang, China
- Inspection
- Jul 7 – Jul 10, 2014
- Investigator
- Kham Phommachanh
- Observations
- 9
- Pages
- 3
- FEI number
- 3008294431
In short: On July 10, 2014, FDA issued a Form 483 with 9 observations to Hubei Meikai Chemical Co., Ltd. in Huanggang, Hubei (FEI 3008294431) after an inspection that ran Jul 7 – Jul 10, 2014. The investigator was Kham Phommachanh. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.194 (3×) · 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
Internal sudit self-inspection established…
- 02
Annual product review (APR) not properly reviewed and approved…
- 03
Certificutes of analysis issued by outside contractor or government agency are not reviewed and approved…
- 04
Each individual test is not separated in the analytical worksheet to distinguish all…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmHubei Meikai Chemical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hubei Meikai Chemical Co., Ltd.?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls 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.
Who inspected Hubei Meikai Chemical Co., Ltd.?
Kham Phommachanh is named on this Form 483, for the inspection of Jul 7 – Jul 10, 2014. Each investigator has a profile showing what they cite most.
When was Hubei Meikai Chemical Co., Ltd. inspected by FDA?
The inspection ran Jul 7 – Jul 10, 2014, and the Form 483 is dated July 10, 2014.
How do I get the full Form 483 for Hubei Meikai Chemical Co., Ltd.?
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