Lilly del Caribe, Inc.
Form 483 issued July 12, 2019 · Carolina, Puerto Rico
- Observations
- 6
- Pages
- 3
- FEI number
- 2619243
In short: On July 12, 2019, FDA issued a Form 483 with 6 observations to Lilly del Caribe, Inc. in Carolina, Puerto Rico (FEI 2619243). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You have implemented an inadequate NIR model maintenance and validation strategy for the…
- 02
Appropriate controls are not exercised over computer or related automation system controls for the (b) (4)…
- 03
Your Quality Unit inadequately classifies manufacturing deviations as observations under…
- 04
You have failed to perform adequate investigations, root cause analysis and corrective actions for observed non…
This inspection in context
Questions about this 483
What did FDA find at Lilly del Caribe, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Lilly del Caribe, Inc. inspected by FDA?
This Form 483 is dated July 12, 2019.
How do I get the full Form 483 for Lilly del Caribe, Inc.?
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.