Swabplus, L.P
Form 483 issued August 1, 2023 · Rancho Cucamonga, California
- Inspection
- Jul 25 – Aug 1, 2023
- Investigator
- Christopher R. Czajka
- Observations
- 10
- Pages
- 10
- FEI number
- 3003053677
In short: On August 1, 2023, FDA issued a Form 483 with 10 observations to Swabplus, L.P in Rancho Cucamonga, California (FEI 3003053677) after an inspection that ran Jul 25 – Aug 1, 2023. The investigator was Christopher R. Czajka. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganis ms in ding pi oducts not required to be…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
The responsibilities and procediues applicable to the quality control unit are not in…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSwabplus, L.P history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Swabplus, L.P?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Swabplus, L.P?
Christopher R. Czajka is named on this Form 483, for the inspection of Jul 25 – Aug 1, 2023. Each investigator has a profile showing what they cite most.
When was Swabplus, L.P inspected by FDA?
The inspection ran Jul 25 – Aug 1, 2023, and the Form 483 is dated August 1, 2023.
How do I get the full Form 483 for Swabplus, L.P?
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.