Waterstone Pharmaceuticals (Hubei) Co., Ltd.
Form 483 issued September 29, 2021 · Tianmen, China
- Inspection
- Aug 3 – Sep 29, 2021
- Investigator
- Tonia F. Bernard
- Observations
- 2
- Pages
- 2
- FEI number
- 3010777606
In short: On September 29, 2021, FDA issued a Form 483 with 2 observations to Waterstone Pharmaceuticals (Hubei) Co., Ltd. in Tianmen, Hubei (FEI 3010777606) after an inspection that ran Aug 3 – Sep 29, 2021. The investigator was Tonia F. Bernard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (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
Repeat observation from the previous FDA inspection. Buildings used in the manufacturing of active pharmaceutical ingredients…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Tonia F. Bernard
13 documents · 2016–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmWaterstone Pharmaceuticals (Hubei) Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Waterstone Pharmaceuticals (Hubei) Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Waterstone Pharmaceuticals (Hubei) Co., Ltd.?
Tonia F. Bernard is named on this Form 483, for the inspection of Aug 3 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was Waterstone Pharmaceuticals (Hubei) Co., Ltd. inspected by FDA?
The inspection ran Aug 3 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
How do I get the full Form 483 for Waterstone Pharmaceuticals (Hubei) 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.