Olein Recovery Corp
Form 483 issued March 18, 2021 · Yabucoa, Puerto Rico
- Inspection
- Mar 8 – Mar 18, 2021
- Investigator
- Santos E. Camara
- Observations
- 4
- Pages
- 5
- FEI number
- 3016690364
In short: On March 18, 2021, FDA issued a Form 483 with 4 observations to Olein Recovery Corp in Yabucoa, Puerto Rico (FEI 3016690364) after an inspection that ran Mar 8 – Mar 18, 2021. The investigator was Santos E. Camara. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
GMP training is not conducted to assure that employees remain familiar with CGMP…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
- 04
A system by which the distribution of each lot of drug product can be readily determined…
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 firmOlein Recovery Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Olein Recovery Corp?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Olein Recovery Corp?
Santos E. Camara is named on this Form 483, for the inspection of Mar 8 – Mar 18, 2021. Each investigator has a profile showing what they cite most.
When was Olein Recovery Corp inspected by FDA?
The inspection ran Mar 8 – Mar 18, 2021, and the Form 483 is dated March 18, 2021.
How do I get the full Form 483 for Olein Recovery Corp?
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.