API Resources LLC
Form 483 issued January 28, 2016 · San Antonio, Texas
- Inspection
- Jan 26 – Jan 28, 2016
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 2
- Pages
- 1
- FEI number
- 3009403153
In short: On January 28, 2016, FDA issued a Form 483 with 2 observations to API Resources LLC in San Antonio, Texas (FEI 3009403153) after an inspection that ran Jan 26 – Jan 28, 2016. The investigator was Patty P. Kaewussdangkul. Most observations concern materials and packaging & labeling; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and packaging & labeling account for 2 of 2 observations.
Most cited: 21 CFR 211.80 (1×) · 211.125 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each lot of active pharmaceutical ingredient received from your supplier was net appropriately identified as to…
- 02
Strict control is not exercised over labeling issued for use in…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAPI Resources LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at API Resources LLC?
FDA listed 2 observations on this Form 483, mostly about materials and packaging & labeling. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected API Resources LLC?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Jan 26 – Jan 28, 2016. Each investigator has a profile showing what they cite most.
When was API Resources LLC inspected by FDA?
The inspection ran Jan 26 – Jan 28, 2016, and the Form 483 is dated January 28, 2016.
How do I get the full Form 483 for API Resources LLC?
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.