CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED
Form 483 issued January 15, 2022 · Shamshabad, India
- Inspection
- Jan 4 – Jan 15, 2022
- Investigator
- Kellia N. Hicks
- Observations
- 6
- Pages
- 16
- FEI number
- 3015283219
In short: On January 15, 2022, FDA issued a Form 483 with 6 observations to CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED in Shamshabad, Telangana (FEI 3015283219) after an inspection that ran Jan 4 – Jan 15, 2022. The investigator was Kellia N. Hicks. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.113(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 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED?
Kellia N. Hicks is named on this Form 483, for the inspection of Jan 4 – Jan 15, 2022. Each investigator has a profile showing what they cite most.
When was CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED inspected by FDA?
The inspection ran Jan 4 – Jan 15, 2022, and the Form 483 is dated January 15, 2022.
How do I get the full Form 483 for CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED?
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