Agropharma Laboratories Inc
Form 483 issued February 12, 2016 · Salinas, Puerto Rico
- Inspection
- Jan 11 – Feb 12, 2016
- Investigator
- Jose Velez
- Observations
- 13
- Pages
- 12
- FEI number
- 3000203462
In short: On February 12, 2016, FDA issued a Form 483 with 13 observations to Agropharma Laboratories Inc in Salinas, Puerto Rico (FEI 3000203462) after an inspection that ran Jan 11 – Feb 12, 2016. The investigator was Jose Velez. Most observations concern quality system and dietary supplement CGMP; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and reject…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The responsibilities and procedures applicable to the quality control unit are…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAgropharma Laboratories Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Agropharma Laboratories Inc?
FDA listed 13 observations on this Form 483, mostly about quality system, dietary supplement CGMP and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Agropharma Laboratories Inc?
Jose Velez is named on this Form 483, for the inspection of Jan 11 – Feb 12, 2016. Each investigator has a profile showing what they cite most.
When was Agropharma Laboratories Inc inspected by FDA?
The inspection ran Jan 11 – Feb 12, 2016, and the Form 483 is dated February 12, 2016.
How do I get the full Form 483 for Agropharma Laboratories 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.