Faencal Tartaric Products, Inc
Form 483 issued March 29, 2016 · Fresno, California
- Inspection
- Mar 14 – Mar 29, 2016
- Observations
- 11
- Pages
- 5
- FEI number
- 1000123669
In short: On March 29, 2016, FDA issued a Form 483 with 11 observations to Faencal Tartaric Products, Inc in Fresno, California (FEI 1000123669) after an inspection that ran Mar 14 – Mar 29, 2016. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings and facilities used to manufacture Potassium Bitartrate, an Active Pharmaceutical Ingredient (API), and its intermediates…
- 02
Equipment used in the manufacture, processing, packing or holding of Potassium Bitartrate is not of appropriate…
- 03
Written procedures are not established and followed for cleaning and maintenance of equipment, including utensils, used…
- 04
Failure to establish a written testing program designed to assess the stability characteristics of Potassium Bitartrate…
This inspection in context
Questions about this 483
What did FDA find at Faencal Tartaric Products, Inc?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Faencal Tartaric Products, Inc inspected by FDA?
The inspection ran Mar 14 – Mar 29, 2016, and the Form 483 is dated March 29, 2016.
How do I get the full Form 483 for Faencal Tartaric Products, 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.