Hubei HONCH Pharmaceutical Co., Ltd.
Form 483 issued March 22, 2019 · Huanggang, China
- Observations
- 2
- Pages
- 1
- FEI number
- 3009478588
In short: On March 22, 2019, FDA issued a Form 483 with 2 observations to Hubei HONCH Pharmaceutical Co., Ltd. in Huanggang, Hubei (FEI 3009478588). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing, or holding of a drug substance do not have…
- 02
Failure to maintain a backup file of electronic data entered into the computer or related system…
This inspection in context
Questions about this 483
What did FDA find at Hubei HONCH Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Hubei HONCH Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated March 22, 2019.
How do I get the full Form 483 for Hubei HONCH Pharmaceutical 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.