Yichang Humanwell Oral Solid Dosage Plant
Form 483 issued November 16, 2020 · Yichang, China
- Observations
- 2
- Pages
- 2
- FEI number
- 3008984460
In short: On November 16, 2020, FDA issued a Form 483 with 2 observations to Yichang Humanwell Oral Solid Dosage Plant in Yichang, Hubei (FEI 3008984460). Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include in-process results for each batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at Yichang Humanwell Oral Solid Dosage Plant?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
When was Yichang Humanwell Oral Solid Dosage Plant inspected by FDA?
This Form 483 is dated November 16, 2020.
How do I get the full Form 483 for Yichang Humanwell Oral Solid Dosage Plant?
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.