Hisun Pfizer Pharmaceuticals Co., Ltd
Form 483 issued April 24, 2015 · Fuyang, China
- Inspection
- Apr 20 – Apr 24, 2015
- Investigators
- Miguacl Martinez· Parul M. Patel
- Observations
- 6
- Pages
- 7
- FEI number
- 3010820594
In short: On April 24, 2015, FDA issued a Form 483 with 6 observations to Hisun Pfizer Pharmaceuticals Co., Ltd in Fuyang, Zhejiang (FEI 3010820594) after an inspection that ran Apr 20 – Apr 24, 2015. The investigators were Miguacl Martinez and Parul M. Patel. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.68 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm has NO data to support the containment of^ QES products such as ®^H^ and…
- 02
Laboratory controls were not…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Deviations from written laboratory…
This inspection in context
Miguacl Martinez
1 document · 2015
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmHisun Pfizer Pharmaceuticals Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hisun Pfizer Pharmaceuticals Co., Ltd?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Hisun Pfizer Pharmaceuticals Co., Ltd?
Miguacl Martinez and Parul M. Patel are named on this Form 483, for the inspection of Apr 20 – Apr 24, 2015. Each investigator has a profile showing what they cite most.
When was Hisun Pfizer Pharmaceuticals Co., Ltd inspected by FDA?
The inspection ran Apr 20 – Apr 24, 2015, and the Form 483 is dated April 24, 2015.
How do I get the full Form 483 for Hisun Pfizer Pharmaceuticals 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.