Destileria Serralles, Inc
Form 483 issued August 9, 2016 · Mercedita, Puerto Rico
- Inspection
- Jul 28 – Aug 9, 2016
- Investigators
- Jose Velez· Marian E. Ramirez
- Observations
- 12
- Pages
- 9
- FEI number
- 3009888617
In short: On August 9, 2016, FDA issued a Form 483 with 12 observations to Destileria Serralles, Inc in Mercedita, Puerto Rico (FEI 3009888617) after an inspection that ran Jul 28 – Aug 9, 2016. The investigators were Jose Velez and Marian E. Ramirez. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, ding…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 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 firmDestileria Serralles, Inc history
All 2 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 Destileria Serralles, Inc?
FDA listed 12 observations on this Form 483, mostly about materials, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Destileria Serralles, Inc?
Jose Velez and Marian E. Ramirez are named on this Form 483, for the inspection of Jul 28 – Aug 9, 2016. Each investigator has a profile showing what they cite most.
When was Destileria Serralles, Inc inspected by FDA?
The inspection ran Jul 28 – Aug 9, 2016, and the Form 483 is dated August 9, 2016.
How do I get the full Form 483 for Destileria Serralles, 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.