580 Garcia Ave
Form 483 issued January 26, 2016 · Pittsburg, California
- Inspection
- Jan 13 – Jan 26, 2016
- Investigator
- Anh Lac
- Observations
- 4
- Pages
- 3
- FEI number
- 1000123641
In short: On January 26, 2016, FDA issued a Form 483 with 4 observations to 580 Garcia Ave in Pittsburg, California (FEI 1000123641) after an inspection that ran Jan 13 – Jan 26, 2016. The investigator was Anh Lac. Most observations concern facilities & equipment and materials; 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
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
- 02
Drug products are not stored under appropriate conditions of so that their identity, strength, quality, and…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firm580 Garcia Ave history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 580 Garcia Ave?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials 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 580 Garcia Ave?
Anh Lac is named on this Form 483, for the inspection of Jan 13 – Jan 26, 2016. Each investigator has a profile showing what they cite most.
When was 580 Garcia Ave inspected by FDA?
The inspection ran Jan 13 – Jan 26, 2016, and the Form 483 is dated January 26, 2016.
How do I get the full Form 483 for 580 Garcia Ave?
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.