Biocosmetica Exel Argentina SRL
Form 483 issued July 7, 2022 · San Justo, Argentina
- Inspection
- Jul 4 – Jul 7, 2022
- Investigator
- Kham Phommachanh
- Observations
- 8
- Pages
- 3
- FEI number
- 3003918735
In short: On July 7, 2022, FDA issued a Form 483 with 8 observations to Biocosmetica Exel Argentina SRL in San Justo, Buenos Aires (FEI 3003918735) after an inspection that ran Jul 4 – Jul 7, 2022. The investigator was Kham Phommachanh. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and materials account for 5 of 8 observations.
Most cited: 21 CFR 211.84(d)(2) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Each component is not tested for conformity with all appropriate written specifications for…
- 03
Input to and output from the computer, related systems of formulas and records or data are…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmBiocosmetica Exel Argentina SRL history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocosmetica Exel Argentina SRL?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. 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 Biocosmetica Exel Argentina SRL?
Kham Phommachanh is named on this Form 483, for the inspection of Jul 4 – Jul 7, 2022. Each investigator has a profile showing what they cite most.
When was Biocosmetica Exel Argentina SRL inspected by FDA?
The inspection ran Jul 4 – Jul 7, 2022, and the Form 483 is dated July 7, 2022.
How do I get the full Form 483 for Biocosmetica Exel Argentina SRL?
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