Laboratorio Reig Jofre, S.A.
Form 483 issued April 5, 2019 · Barcelona, Spain
- Inspection
- Mar 25 – Apr 5, 2019
- Investigator
- Santos E. Camara
- Observations
- 8
- Pages
- 7
- FEI number
- 3003768199
In short: On April 5, 2019, FDA issued a Form 483 with 8 observations to Laboratorio Reig Jofre, S.A. in Barcelona, Spain (FEI 3003768199) after an inspection that ran Mar 25 – Apr 5, 2019. The investigator was Santos E. Camara. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into the failure of a batch or any…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to prevent microbiological contamination of drug products. purporting to be sterile did not include…
- 04
Observation 4: scanned text, readable in the full document.
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 firmLaboratorio Reig Jofre, S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratorio Reig Jofre, S.A.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Laboratorio Reig Jofre, S.A.?
Santos E. Camara is named on this Form 483, for the inspection of Mar 25 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Laboratorio Reig Jofre, S.A. inspected by FDA?
The inspection ran Mar 25 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
How do I get the full Form 483 for Laboratorio Reig Jofre, S.A.?
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.