Lee Pharma Limited
Form 483 issued November 2, 2018 · Sangareddy, India
- Inspection
- Oct 29 – Nov 2, 2018
- Investigator
- Tiara N. Brown-Crosen
- Observations
- 6
- Pages
- 4
- FEI number
- 3009103626
In short: On November 2, 2018, FDA issued a Form 483 with 6 observations to Lee Pharma Limited in Sangareddy, Telangana (FEI 3009103626) after an inspection that ran Oct 29 – Nov 2, 2018. The investigator was Tiara N. Brown-Crosen. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
4 of 6 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 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
Analytical methods used in testing process validation…
- 02
Stability samples are not stored under…
- 03
Analytical methods used in testing stability…
- 04
Your hold time stability study protocol does not ensure stability samples are packaged in a manner…
This inspection in context
Tiara N. Brown-Crosen
7 documents · 2016–2019
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Missouri.
The firmLee Pharma Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lee Pharma Limited?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Lee Pharma Limited?
Tiara N. Brown-Crosen is named on this Form 483, for the inspection of Oct 29 – Nov 2, 2018. Each investigator has a profile showing what they cite most.
When was Lee Pharma Limited inspected by FDA?
The inspection ran Oct 29 – Nov 2, 2018, and the Form 483 is dated November 2, 2018.
How do I get the full Form 483 for Lee Pharma 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.