Form 483 · FEI 1000150986
Form 483 issued May 25, 2018 · Sandpoint, Idaho
- Inspection
- Apr 16 – May 25, 2018
- Investigator
- Gloria J. Baca
- Observations
- 2
- Pages
- 2
- FEI number
- 1000150986
In short: On May 25, 2018, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Sandpoint, Idaho (FEI 1000150986) after an inspection that ran Apr 16 – May 25, 2018. The investigator was Gloria J. Baca. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.113(a) (1×) · 211.170(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
A sample which is representative of each lot in each shipment of each active…
This inspection in context
Gloria J. Baca
5 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmSite history
All 3 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 an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. 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?
Gloria J. Baca is named on this Form 483, for the inspection of Apr 16 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 16 – May 25, 2018, and the Form 483 is dated May 25, 2018.
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.