SAFC Carlsbad Inc.
Form 483 issued December 16, 2021 · Carlsbad, California
- Inspection
- Dec 7 – Dec 16, 2021
- Investigator
- Lauren M. Lilly
- Observations
- 7
- Pages
- 6
- FEI number
- 3012673301
In short: On December 16, 2021, FDA issued a Form 483 with 7 observations to SAFC Carlsbad Inc. in Carlsbad, California (FEI 3012673301) after an inspection that ran Dec 7 – Dec 16, 2021. The investigator was Lauren M. Lilly. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Biohazardous disposal containers are…
- 03
Given the previous conditions pointed out about the cleaning of biohazardous waste containers and handling of…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Lauren M. Lilly
5 documents · 2020–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmSAFC Carlsbad Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SAFC Carlsbad Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected SAFC Carlsbad Inc.?
Lauren M. Lilly is named on this Form 483, for the inspection of Dec 7 – Dec 16, 2021. Each investigator has a profile showing what they cite most.
When was SAFC Carlsbad Inc. inspected by FDA?
The inspection ran Dec 7 – Dec 16, 2021, and the Form 483 is dated December 16, 2021.
How do I get the full Form 483 for SAFC Carlsbad Inc.?
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.