Form 483 · FEI 301543430
Form 483 issued June 19, 2020 · Hannans
- Inspection
- Jun 15 – Jun 19, 2020
- Investigators
- Andrew Byrnes· Bo Liang· Priscilla M. Pastrana
- Observations
- 5
- Pages
- 3
- FEI number
- 301543430
In short: On June 19, 2020, FDA issued a Form 483 with 5 observations to an FDA-inspected site in Hannans (FEI 301543430) after an inspection that ran Jun 15 – Jun 19, 2020. The investigators were Andrew Byrnes, Bo Liang, Priscilla M. Pastrana and Wanda E. Pagan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Standard operating procedures (SOPs)…
- 02
Inadequate review and trending…
- 03
Inadequate controls for the prevention…
- 04
Measures to prevent the recurrence of cracks and leaking in cell culture vessels used for…
This inspection in context
Andrew Byrnes
2 documents · 2019–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 5 observations on this Form 483, mostly about quality system, production and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Andrew Byrnes, Bo Liang, Priscilla M. Pastrana and Wanda E. Pagan are named on this Form 483, for the inspection of Jun 15 – Jun 19, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 15 – Jun 19, 2020, and the Form 483 is dated June 19, 2020.
How do I get the full Form 483 for an FDA-inspected site?
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.