Form 483 · FEI 3006624492
Form 483 issued September 18, 2019 · Richmond, California
- Inspection
- Sep 18, 2019
- Investigator
- Andrew K. Haack
- Observations
- 4
- Pages
- 2
- FEI number
- 3006624492
In short: On September 18, 2019, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Richmond, California (FEI 3006624492) after an inspection that ran Sep 18, 2019. The investigator was Andrew K. Haack. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Materials or supplies were not disinfected prior to entering…
- 02
Disinfocting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5…
- 04
Batch production and control records are not prepared for each batch of drug product produced and…
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Andrew K. Haack is named on this Form 483, for the inspection of Sep 18, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 18, 2019, and the Form 483 is dated September 18, 2019.
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.