Solara Active Pharma Sciences Limited
Form 483 issued March 7, 2020 · Cuddalore, India
- Inspection
- Mar 7, 2020
- Investigators
- Dipesh K. Shah· Miguel A. Martinez· Zedong Dong
- Observations
- 6
- Pages
- 11
- FEI number
- 3003585876
In short: On March 7, 2020, FDA issued a Form 483 with 6 observations to Solara Active Pharma Sciences Limited in Cuddalore, Tamil Nadu (FEI 3003585876) after an inspection that ran Mar 7, 2020. The investigators were Dipesh K. Shah, Miguel A. Martinez and Zedong Dong. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
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…
- 02
Your firm's cleaning validation program…
- 03
Laboratory records do not include complete records of the periodic…
- 04
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory…
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 firmSolara Active Pharma Sciences Limited history
The site's inspection history, in date order.
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 Solara Active Pharma Sciences Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Solara Active Pharma Sciences Limited?
Dipesh K. Shah, Miguel A. Martinez and Zedong Dong are named on this Form 483, for the inspection of Mar 7, 2020. Each investigator has a profile showing what they cite most.
When was Solara Active Pharma Sciences Limited inspected by FDA?
The inspection ran Mar 7, 2020, and the Form 483 is dated March 7, 2020.
How do I get the full Form 483 for Solara Active Pharma Sciences 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.