South Texas Botanicals
Form 483 issued January 12, 2017 · Beeville, Texas
- Inspection
- Jan 9 – Jan 12, 2017
- Investigator
- Jason R. Caballero
- Observations
- 13
- Pages
- 6
- FEI number
- 3010656208
In short: On January 12, 2017, FDA issued a Form 483 with 13 observations to South Texas Botanicals in Beeville, Texas (FEI 3010656208) after an inspection that ran Jan 9 – Jan 12, 2017. The investigator was Jason R. Caballero. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 8 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing and holding of a drug product are not maintained in…
- 02
There is no quality…
- 03
EMPI.OY'EE(S) SIGNATVRE The batch production and control records are deficient in that they are not an…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmSouth Texas Botanicals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at South Texas Botanicals?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected South Texas Botanicals?
Jason R. Caballero is named on this Form 483, for the inspection of Jan 9 – Jan 12, 2017. Each investigator has a profile showing what they cite most.
When was South Texas Botanicals inspected by FDA?
The inspection ran Jan 9 – Jan 12, 2017, and the Form 483 is dated January 12, 2017.
How do I get the full Form 483 for South Texas Botanicals?
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.