Lantech Pharmaceuticals Limited
Form 483 issued March 15, 2019 · Srikakulam, India
- Inspection
- Mar 5 – Mar 15, 2019
- Investigators
- Dipesh K. Shah· Eric L. Dong· Tenzin Jangchup
- Observations
- 9
- Pages
- 12
- FEI number
- 3012390454
In short: On March 15, 2019, FDA issued a Form 483 with 9 observations to Lantech Pharmaceuticals Limited in Srikakulam, Andhra Pradesh (FEI 3012390454) after an inspection that ran Mar 5 – Mar 15, 2019. The investigators were Dipesh K. Shah, Eric L. Dong and Tenzin Jangchup. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.192 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are inadequate in that they do not evaluate…
- 02
Your firm’s cleaning of…
- 03
Strict controls are not exercised over electronic data related to…
- 04
Your Quality Unit lacks…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLantech Pharmaceuticals Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lantech Pharmaceuticals Limited?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lantech Pharmaceuticals Limited?
Dipesh K. Shah, Eric L. Dong and Tenzin Jangchup are named on this Form 483, for the inspection of Mar 5 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Lantech Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 5 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Lantech 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.