CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED
Form 483 issued August 29, 2023 · Shamshabad, India
- Inspection
- Aug 21 – Aug 29, 2023
- Investigators
- Lillian S. Wu· Nicole E. Knowlton
- Observations
- 2
- Pages
- 3
- FEI number
- 3015283219
In short: On August 29, 2023, FDA issued a Form 483 with 2 observations to CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED in Shamshabad, Telangana (FEI 3015283219) after an inspection that ran Aug 21 – Aug 29, 2023. The investigators were Lillian S. Wu and Nicole E. Knowlton. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.22(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Lillian S. Wu
11 documents · 2022–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmCRONUS PHARMA SPECIALITIES INDIA 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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED?
Lillian S. Wu and Nicole E. Knowlton are named on this Form 483, for the inspection of Aug 21 – Aug 29, 2023. Each investigator has a profile showing what they cite most.
When was CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED inspected by FDA?
The inspection ran Aug 21 – Aug 29, 2023, and the Form 483 is dated August 29, 2023.
How do I get the full Form 483 for CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED?
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