Sri Krishna Pharmaceuticals Limited
Form 483 issued September 1, 2023 · Hyderabad, India
- Inspection
- Aug 28 – Sep 1, 2023
- Investigators
- Pratik S. Upadhyay· Tamil Arasu
- Observations
- 8
- Pages
- 12
- FEI number
- 3003723117
In short: On September 1, 2023, FDA issued a Form 483 with 8 observations to Sri Krishna Pharmaceuticals Limited in Hyderabad, Telangana (FEI 3003723117) after an inspection that ran Aug 28 – Sep 1, 2023. The investigators were Pratik S. Upadhyay and Tamil Arasu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.67 (2×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit of the firm did not ensure accuracy and…
- 02
Equipment is not cleaned and maintained at appropriate intervals to prevent contamination that would alter the…
- 03
The cleaning validation of equipment…
- 04
Investigation, retesting and resampling of out of specifications results was not performed according…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSri Krishna Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sri Krishna Pharmaceuticals Limited?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Sri Krishna Pharmaceuticals Limited?
Pratik S. Upadhyay and Tamil Arasu are named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Sri Krishna Pharmaceuticals Limited inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Sri Krishna Pharmaceuticals Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.