Destileria Serralles, Inc
Form 483 issued March 11, 2021 · Mercedita, Puerto Rico
- Inspection
- Mar 1 – Mar 11, 2021
- Investigator
- Ariel Cruz Figueroa
- Observations
- 9
- Pages
- 10
- FEI number
- 3009888617
In short: On March 11, 2021, FDA issued a Form 483 with 9 observations to Destileria Serralles, Inc in Mercedita, Puerto Rico (FEI 3009888617) after an inspection that ran Mar 1 – Mar 11, 2021. The investigator was Ariel Cruz Figueroa. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials account for 6 of 9 observations.
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, drug…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) 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 9 observations on this Form 483, mostly about quality system, materials 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 Destileria Serralles, Inc?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Mar 1 – Mar 11, 2021. Each investigator has a profile showing what they cite most.
When was Destileria Serralles, Inc inspected by FDA?
The inspection ran Mar 1 – Mar 11, 2021, and the Form 483 is dated March 11, 2021.
How do I get the full Form 483 for Destileria Serralles, Inc?
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