CAPLIN STERILES LIMITED
Form 483 issued June 14, 2019 · THIRUVALLUR, India
- Inspection
- Jun 6 – Jun 14, 2019
- Observations
- 2
- Pages
- 3
- FEI number
- 3005035920
In short: On June 14, 2019, FDA issued a Form 483 with 2 observations to CAPLIN STERILES LIMITED in THIRUVALLUR, Tamil Nadu (FEI 3005035920) after an inspection that ran Jun 6 – Jun 14, 2019. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Employees engaged in the packing of a drug product lack the training required to…
This inspection in context
Questions about this 483
What did FDA find at CAPLIN STERILES LIMITED?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was CAPLIN STERILES LIMITED inspected by FDA?
The inspection ran Jun 6 – Jun 14, 2019, and the Form 483 is dated June 14, 2019.
How do I get the full Form 483 for CAPLIN STERILES 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.