Form 483 · FEI 3006606138
Form 483 issued June 17, 2022 · CAHERCIVEEN, Ireland
- Inspection
- Jun 13 – Jun 17, 2022
- Investigator
- Santos E. Camara
- Observations
- 4
- Pages
- 4
- FEI number
- 3006606138
In short: On June 17, 2022, FDA issued a Form 483 with 4 observations to an FDA-inspected site in CAHERCIVEEN, Co. Kerry (FEI 3006606138) after an inspection that ran Jun 13 – Jun 17, 2022. The investigator was Santos E. Camara. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Determinations of conformance to appropriate written specifications for acceptance are…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing. Electronic records…
- 03
Routine calibration of mechanical equipment is not performed according to a written program designed…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Santos E. Camara is named on this Form 483, for the inspection of Jun 13 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 13 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
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.