Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Form 483 issued June 14, 2019 · Wuhan, China
- Observations
- 2
- Pages
- 2
- FEI number
- 3010163919
In short: On June 14, 2019, FDA issued a Form 483 with 2 observations to Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd in Wuhan, Hubei (FEI 3010163919). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.180 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records shall be maintained so that data can be used for evaluating, at least (6)(@)…
- 02
Batch production and control records fail to include the complete manufacturing and control instructions, sampling and…
This inspection in context
Questions about this 483
What did FDA find at Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
When was Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd inspected by FDA?
This Form 483 is dated June 14, 2019.
How do I get the full Form 483 for Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd?
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.