SHODHANA LABORATORIES PRIVATE LIMITED
Form 483 issued May 23, 2019 · Hyderabad, India
- Inspection
- May 20 – May 23, 2019
- Investigator
- Gam S. Zamil
- Observations
- 1
- Pages
- 2
- FEI number
- 3010836438
In short: On May 23, 2019, FDA issued a Form 483 with 1 observation to SHODHANA LABORATORIES PRIVATE LIMITED in Hyderabad, India (FEI 3010836438) after an inspection that ran May 20 – May 23, 2019. The investigator was Gam S. Zamil. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing Equipment Cleaning Procedure is not assured to…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmSHODHANA LABORATORIES PRIVATE 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 SHODHANA LABORATORIES PRIVATE LIMITED?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 SHODHANA LABORATORIES PRIVATE LIMITED?
Gam S. Zamil is named on this Form 483, for the inspection of May 20 – May 23, 2019. Each investigator has a profile showing what they cite most.
When was SHODHANA LABORATORIES PRIVATE LIMITED inspected by FDA?
The inspection ran May 20 – May 23, 2019, and the Form 483 is dated May 23, 2019.
How do I get the full Form 483 for SHODHANA LABORATORIES PRIVATE LIMITED?
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