Biocore9
Amended 483 issued November 6, 2023 · Whippany, New Jersey
- Inspection
- Oct 10 – Nov 6, 2023
- Investigators
- Monica L. Gutierrez· Naakesh N. Gomanie· William R. Chang
- Observations
- 12
- Pages
- 12
- FEI number
- 3020162561
In short: On November 6, 2023, FDA issued a Amended 483 with 12 observations to Biocore9 in Whippany, New Jersey (FEI 3020162561) after an inspection that ran Oct 10 – Nov 6, 2023. The investigators were Monica L. Gutierrez, Naakesh N. Gomanie and William R. Chang. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 8 of 12 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Risk analysis is inadequate…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
The results of design validation, including identification of the design, method(s), the date and the individual(s)…
8 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Monica L. Gutierrez
4 documents · 2023–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmBiocore9 history
The site's inspection history, in date order.
Similar documentsOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Biocore9?
FDA listed 12 observations on this Form 483, mostly about design controls, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Biocore9?
Monica L. Gutierrez, Naakesh N. Gomanie and William R. Chang are named on this Amended 483, for the inspection of Oct 10 – Nov 6, 2023. Each investigator has a profile showing what they cite most.
When was Biocore9 inspected by FDA?
The inspection ran Oct 10 – Nov 6, 2023, and the Amended 483 is dated November 6, 2023.
How do I get the full Amended 483 for Biocore9?
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.