SOFTGEL HEALTHCARE PRIVATE LIMITED
Form 483 issued February 22, 2019 · Chengalpattu, India
- Inspection
- Feb 18 – Feb 22, 2019
- Investigator
- Felix Maldonado
- Observations
- 2
- Pages
- 3
- FEI number
- 3006381009
In short: On February 22, 2019, FDA issued a Form 483 with 2 observations to SOFTGEL HEALTHCARE PRIVATE LIMITED in Chengalpattu, Tamilnadu (FEI 3006381009) after an inspection that ran Feb 18 – Feb 22, 2019. The investigator was Felix Maldonado. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.52 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Washing and toilet facilities…
This inspection in context
Felix Maldonado
6 documents · 2009–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmSOFTGEL HEALTHCARE PRIVATE LIMITED 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(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SOFTGEL HEALTHCARE PRIVATE LIMITED?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. 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 SOFTGEL HEALTHCARE PRIVATE LIMITED?
Felix Maldonado is named on this Form 483, for the inspection of Feb 18 – Feb 22, 2019. Each investigator has a profile showing what they cite most.
When was SOFTGEL HEALTHCARE PRIVATE LIMITED inspected by FDA?
The inspection ran Feb 18 – Feb 22, 2019, and the Form 483 is dated February 22, 2019.
How do I get the full Form 483 for SOFTGEL HEALTHCARE PRIVATE LIMITED?
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